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E-cigarette: Safety Communication - Related to Seizures Reported Following E-cigarette Use, Particularly in Youth and Young Adults
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4/3/2019
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4:00 AM
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FDA MedWatch RSS Feed
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The FDA has become aware that some people who use e-cigarettes have experienced seizures, with most reports involving youth or young adult users.
Full Article
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Xeljanz, Xeljanz XR (tofacitinib): Safety Communication - Safety Trial Finds Increased Risk of Blood Clots in the Lungs and Death with Higher Dose in Rheumatoid Arthritis Patients
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2/25/2019
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5:00 AM
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FDA MedWatch RSS Feed
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FDA is alerting the public that a safety clinical trial found an increased risk of blood clots in the lungs and death when a 10 mg twice daily dose of tofacitinib (Xeljanz, Xeljanz XR) was used in patients with rheumatoid arthritis (RA). FDA has not approved this 10 mg twice daily dose for RA; this dose is only approved in the dosing regimen for patients with ulcerative colitis
Full Article
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Fluoroquinolone Antibiotics: Safety Communication - Increased Risk of Ruptures or Tears in the Aorta Blood Vessel in Certain Patients
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12/20/2018
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5:00 AM
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FDA MedWatch RSS Feed
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FDA review found that fluoroquinolone antibiotics can increase the occurrence of rare but serious events of ruptures or tears in the main artery of the body, called the aorta. These tears, called aortic dissections, or ruptures of an aortic aneurysm can lead to dangerous bleeding or even death. They can occur with fluoroquinolones for systemic use given by mouth or through an injection.
Full Article
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Gilenya (fingolimod): Drug Safety Communication - Severe Worsening of Multiple Sclerosis After Stopping the Medicine
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11/20/2018
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5:00 AM
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FDA MedWatch RSS Feed
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FDA is warning that when the multiple sclerosis (MS) medicine Gilenya (fingolimod) is stopped, the disease can become much worse than before the medicine was started or while it was being taken. This MS worsening is rare but can result in permanent disability.
Full Article
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Implanted Pumps: Safety Communication - Use Caution When Selecting Pain Medicine for Intrathecal Administration
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11/14/2018
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5:00 AM
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FDA MedWatch RSS Feed
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The FDA is aware that patients undergoing treatment or management of pain are commonly given pain medicines in the spinal fluid (intrathecal administration) that are not FDA approved for use with the implanted pump.
Full Article
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SGLT2(sodium-glucose cotransporter-2) Inhibitors for Diabetes: Drug Safety Communication - Regarding Rare Occurrences of a Serious Infection of the Genital Area
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8/29/2018
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4:00 AM
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FDA MedWatch RSS Feed
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Requiring a new warning about this risk to be added to the prescribing information of all SGLT2 inhibitors and to the patient Medication Guide.
Full Article
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Temporary Total Artificial Heart Companion 2 Driver System by SynCardia Systems: Letter to Health Care Providers - Risk of Mortality and Stroke
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8/17/2018
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3:00 PM
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FDA MedWatch RSS Feed
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FDA has reviewed the final results from the post-approval study conducted by SynCardia Systems, LLC. for their Temporary Total Artificial Heart (TAH-t) Companion 2 Driver System (C2 Driver System). These final results indicate a higher mortality rate and higher stroke rate for patients initially supported with the C2 Driver System compared to patients initially supported with the previous generation driver, the Circulatory Support System (CSS) Console.
Full Article
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Risks Associated with Use of Rupture of Membranes Tests - Letter to Health Care Providers
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8/8/2018
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6:00 PM
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FDA MedWatch RSS Feed
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The FDA is reminding health care providers that tests to detect rupture of the amniotic membranes should not be used without other clinical assessments to make critical patient management decisions.
Full Article
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Zithromax, Zmax (azithromycin): FDA Warning - Increased Risk of Cancer Relapse With Long-Term Use After Donor Stem Cell Transplant
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8/3/2018
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2:00 PM
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FDA MedWatch RSS Feed
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The antibiotic Zithromax, Zmax (azithromycin) should not be given long-term to prevent a certain inflammatory lung condition in patients with cancers of the blood or lymph nodes who undergo a donor stem cell transplant. Results of a clinical trial found an increased rate of relapse in cancers affecting the blood and lymph nodes, including death, in these patients.
Full Article
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Valsartan-Containing Products: Update Health Professional and Consumer on Recent Recalled Products
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7/19/2018
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4:00 AM
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FDA MedWatch RSS Feed
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The investigation into valsartan-containing products is ongoing and there are currently three voluntary recalls related to the NDMA impurity detected in the valsartan
Full Article
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Fluoroquinolone Antibiotics: FDA Requires Labeling Changes Due to Low Blood Sugar Levels and Mental Health Side Effects
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7/10/2018
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5:00 PM
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FDA MedWatch RSS Feed
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FDA is strengthening the current warnings in the prescribing information that fluoroquinolone antibiotics may cause significant decreases in blood sugar and certain mental health side effects.
Full Article
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Kratom (mitragyna speciosa) Powder Products by Gaia Ethnobotanical: Recall - Due to Potential Salmonella Contamination
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6/22/2018
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3:00 PM
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FDA MedWatch RSS Feed
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The products have been found by the FDA via sample testing and finding to have salmonella contamination. In lieu of such FDA findings the company has implemented standard operating procedures and sterilization processes in accordance to FDA guidelines
Full Article
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Various Aortic Endovascular Graft Systems: Letter to Health Care Providers - UPDATE on Type III Endoleaks
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6/19/2018
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3:30 PM
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FDA MedWatch RSS Feed
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Based on new information, the Endologix AFX with Strata device is at greater risk for a Type III endoleak compared to other endovascular AAA graft systems.
Full Article
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Compounded Products Containing Triamcinolone-Moxifloxacin by Guardian Pharmacy Services (Dallas, Texas): Alert to Health Professionals - Adverse Events Reported After Receiving Eye Injections
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6/15/2018
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1:00 AM
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FDA MedWatch RSS Feed
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At least 43 patient reported adverse event after receiving eye injections of Guardian?s Pharmacy Services compounded triamcinolone-moxifloxacin product during cataract surgery. The patients reportedly experienced various symptoms, including vision impairment, poor night vision, loss of color perception, and significant reductions in best-corrected visual acuity and visual fields.
FDA identified multiple substances in Guardian?s product, including poloxamer 407 and poloxamer 407 degradants. FDA prepared in-house samples of Guardian?s product and found that autoclaving and sonication caused the poloxamer 407 to degrade. The amount of poloxamer 407 in Guardian?s product (12%, g/100 mL) is much greater than the maximum amount of poloxamers in FDA-approved ophthalmic products for topical administration (0.1-0.2%, g/100 mL), and the safety profile of drug products intended for intravitreal injection containing poloxamer 407 is unknown.
Full Article
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Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL in the Carpuject™ Single-use Cartridge Syringe System by Hospira: Recall - Due to the Potential Presence of Particulate Matter
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6/4/2018
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4:00 AM
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FDA MedWatch RSS Feed
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The patient has a low likelihood of experiencing adverse events ranging from local irritation, allergic reactions, phlebitis, end-organ granuloma, tissue ischemia, pulmonary emboli, pulmonary dysfunction, pulmonary infarction, and toxicity.
Full Article
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Liquid-filled Intragastric Balloons by Apollo Endosurgery and ReShape Lifesciences: Letter to Health Care Providers - New Labeling About Potential Risks
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6/4/2018
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4:00 AM
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FDA MedWatch RSS Feed
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FDA has approved new labeling for the Orbera and ReShape balloon systems with more information about possible death associated with the use of these devices.
Full Article
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HeartWare HVAD System by Medtronic: Class I Recall - Due to Unintended Intermittent Electrical Disconnection between the Power Source and the Controller
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6/1/2018
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4:00 AM
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FDA MedWatch RSS Feed
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Interruptions to the electrical connection could cause a pump stop. A pump stop could cause patient harm such as exacerbation of heart failure symptoms, or symptoms such as mild weakness, loss of consciousness, or death.
Full Article
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STAT-Check and Medline Manual Resuscitator Bags by SunMed Holdings: Recall - Patient Port May Detach During Use
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6/1/2018
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4:00 AM
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FDA MedWatch RSS Feed
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The patient port retaining ring of the affected bags may not fully seat which may allow the patient port to detach during use.
Full Article
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Fluticasone Propionate Nasal Spray by Apotex Corp: Recall - Due to Potential for Small Glass Particles
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5/31/2018
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6:00 PM
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FDA MedWatch RSS Feed
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The glass particles could block the actuator and impact the functionality of the pump and expose patients to the glass particles.
Full Article
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TAYTULLA (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules) by Allergan: Recall - Due to Out of Sequence Capsules
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5/29/2018
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6:00 PM
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FDA MedWatch RSS Feed
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Allergan recently identified, through a physician report, that four placebo capsules were placed out of order in a sample pack of TAYTULLA. Specifically, the first four days of therapy had four non-hormonal placebo capsules instead of active capsules.
As a result of this packaging error, oral contraceptive capsules, that are taken out of sequence, may place the user at risk for contraceptive failure and unintended pregnancy. The reversing of the order may not be apparent to either new users or previous users of the product, increasing the likelihood of taking the capsules out of order. If patients have concerns regarding the possibility of an unintended pregnancy they should consult their physician.
Full Article
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X-Jow and Acne Shave Products by Shadow Holdings: Voluntary Recall - Due to Possible Bacterial Contamination
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5/29/2018
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1:00 PM
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FDA MedWatch RSS Feed
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The products may be contaminated with bacteria. Topical administration of the products could result in potentially serious bacterial infections in immunocompromised individuals.
Full Article
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Oral Over-the-Counter Benzocaine Products: Drug Safety Communication - Risk of Serious and Potentially Fatal Blood Disorder
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5/23/2018
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4:00 AM
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FDA MedWatch RSS Feed
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Oral over-the-counter benzocaine products should not be used to treat infants and children younger than 2 years and should only be used in adults and children 2 years and older if they contain certain warnings on the drug label.
Full Article
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95% Ethyl Alcohol Product by Ethanol Extraction: Recall - Due to a Possible Contamination with Methanol
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5/23/2018
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4:00 AM
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FDA MedWatch RSS Feed
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Methanol,a highly toxic type of alcohol, can cause serious and sometimes fatal damage if ingested by humans or animals.
Full Article
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HeartMate 3? Left Ventricular Assist System: Class I Recall - Due to Potential Malfunction that may Lead to Graft Occlusion
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5/22/2018
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2:00 PM
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FDA MedWatch RSS Feed
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The class I recall is due to a malfunction in the device?s outflow graft assembly that may cause the outflow graft to twist and close up (occlusion) over time. Occlusion of the outflow graft can reduce or stop pump flow and set off a persistent low flow alarm in the system. A reduction in pump can lead to serious adverse events such as blood clots and death.
Full Article
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Homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir by MBI Distributing: Recall - Due to a Lack of Adequate Controls
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5/21/2018
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4:00 AM
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FDA MedWatch RSS Feed
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Manufacturing products without proper process controls increases the probability that products will vary in strength, quality and purity
Full Article
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Juluca, Tivicay, Triumeq (dolutegravir): FDA to Evaluate - Potential Risk of Neural Tube Birth Defects
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5/18/2018
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4:00 PM
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FDA MedWatch RSS Feed
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Preliminary results from an ongoing observational study in Botswana found that women who received dolutegravir at the time of becoming pregnant or early in the first trimester appear to be at higher risk for these defects.
Neural tube defects are birth defects that can occur early in pregnancy when the spinal cord, brain, and related structures do not form properly. To date, in this observational study there are no reported cases of babies born with neural tube defects to women starting dolutegravir later in pregnancy. We are investigating this new safety issue and will update the public when we have more information.
Full Article
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Keytruda (pembrolizumab) or Tecentriq (atezolizumab): FDA Alerts Health Care Professionals and Investigators: FDA Statement - Decreased Survival in Some Patients in Clinical Trials Associated with Monotherapy
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5/18/2018
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4:00 AM
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FDA MedWatch RSS Feed
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Early reviews found patients in the monotherapy arms of both trials with PD-L1 low status had decreased survival compared to patients who received cisplatin- or carboplatin-based chemotherapy.
Full Article
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Piperacillin and Tazobactam for Injection, USP 3.375 g Vials by AuroMedics Pharma: Recall - Vials Contain Particulate Matter
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5/8/2018
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4:00 AM
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FDA MedWatch RSS Feed
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Piperacillin and Tazobactam for Injection, USP 3.375 g by AuroMedics Pharma: Recall: Exposure to particulate matter may result in local irritation/swelling or more serious outcomes.
Full Article
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Ampicillin and Sulbactam for Injection USP, 3 g Single-Dose Vials by AuroMedics Pharma: Recall - Presence of Red Particulate Matter
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5/8/2018
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4:00 AM
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FDA MedWatch RSS Feed
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Ampicillin and Sulbactam for Injection USP, 3 g/Single-Dose Vials by AuroMedics Pharma: Recall - Exposure to particulate may result in local site reaction, thromboembolic events and systemic immune response.
Full Article
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Lamictal (lamotrigine): Drug Safety Communication - Serious Immune System Reaction
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4/25/2018
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4:00 AM
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FDA MedWatch RSS Feed
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The FDA is warning that the medicine lamotrigine (Lamictal) for seizures and bipolar disorder can cause a rare but very serious reaction that excessively activates the body?s infection-fighting immune system. This can cause severe inflammation throughout the body and lead to hospitalization and death, especially if the reaction is not diagnosed and treated quickly. As a result, we are requiring a new warning about this risk be added to the prescribing information in the lamotrigine drug labels. The immune system reaction, called hemophagocytic lymphohistiocytosis (HLH), causes an uncontrolled response by the immune system. HLH typically presents as a persistent fever, usually greater than 101?F, and it can lead to severe problems with blood cells and organs throughout the body such as the liver, kidneys, and lungs.
Full Article
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Magnetic Resonance-guided Laser Interstitial Thermal Therapy (MRgLITT) Devices: Letter to Health Care Providers - Risk of Tissue Overheating Due to Inaccurate Magnetic Resonance Thermometry
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4/25/2018
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4:00 AM
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FDA MedWatch RSS Feed
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FDA is currently evaluating data which suggests that potentially inaccurate MR thermometry information can be displayed during treatment. Posted 04/25/2018
Full Article
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Rhino 69 Extreme 50000 by AMA Wholesale: Recall - Presence of Tadalafil
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4/18/2018
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4:00 AM
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FDA MedWatch RSS Feed
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Consumers with diabetes, hypertension, high cholesterol or heart disease often take nitrates; concomitant use of nitrates and PDE5 inhibitors can lead to fatal cardiovascular collapse. Posted 04/18/2018
Full Article
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Euphoric Capsules by Epic Products: Recall - Undeclared Sildenafil and Tadalafil
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4/18/2018
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4:00 AM
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FDA MedWatch RSS Feed
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Consumers with diabetes, hypertension, high cholesterol or heart disease often take nitrates; concomitant use of nitrates and PDE-5 inhibitors can lead to fatal cardiovascular collapse. Posted 04/18/2018
Full Article
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Certain Implantable Cardiac Devices by Abbott (formerly St. Jude Medical): FDA Safety Communication - Battery Performance Alert and Cybersecurity Firmware Updates
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4/17/2018
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4:00 AM
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FDA MedWatch RSS Feed
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If the battery runs out, the ICD or CRT-D will be unable to deliver life-saving pacing or shocks, which could lead to patient death. Posted 04/17/2018
Full Article
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Acrodose PLus and PL Systems by Haemonetics: Recall - Low pH Readings for Platelets Stored in CLX HP Bag
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4/13/2018
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1:00 PM
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FDA MedWatch RSS Feed
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Platelets with pH lower than 6.2 and a lack of ?swirl? may not be viable. Transfusion of these platelets may lead to delayed correction of coagulopathy or low quality prophylactic platelet transfusion.
Full Article
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Coastal Meds to Recall All Products Marketed as Sterile
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4/13/2018
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4:00 AM
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FDA MedWatch RSS Feed
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FDA is alerting health care professionals to a voluntary recall of all non-expired products marketed as sterile made by Coastal Meds due to visible particles in some of the drug vials for injection.
Full Article
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Sterile Injectable Products by Premier Pharmacy Labs: Recall - Lack of Sterility Assurance
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4/12/2018
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2:00 PM
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FDA MedWatch RSS Feed
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Administration of non-sterile injection products that are intended to be sterile may result in a site-specific or systemic infection.
Full Article
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System 83 Plus Automated Endoscope Reprocessors (AERs) by Custom Ultrasonics: FDA Safety Communication - Completed Validation Testing
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4/10/2018
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6:50 PM
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FDA MedWatch RSS Feed
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System 83 Plus AERs may now be used to reprocess only the Olympus TJF-Q180V duodenoscope and the Pentax ED-3490TK duodenoscope.
Full Article
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Maeng Da Red Powder and Capsules by Club 13: Recall - Possible Contamination With Salmonella
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4/10/2018
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2:50 PM
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FDA MedWatch RSS Feed
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Salmonella can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.
Full Article
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Essure Permanent Birth Control System by Bayer Healthcare: Announcement - FDA Restricts the Sale and Distribution
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4/9/2018
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5:00 PM
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FDA MedWatch RSS Feed
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Sales restricted to only doctors and healthcare facilities who use the FDA-approved “Patient-Doctor Discussion Checklist – Acceptance of Risk and Informed Decision Acknowledgement”.
Full Article
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Kratom-containing Products by Triangle Pharmanaturals: Mandatory Recall - Risk of Salmonella
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4/3/2018
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6:00 PM
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FDA MedWatch RSS Feed
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Salmonella bacteria can cause the foodborne illness salmonellosis. Most people infected with salmonella develop diarrhea, fever and abdominal cramps 12 to 72 hours after infection.
Full Article
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Dietary Supplements by Nutrizone: Recall - Potential for Salmonella Contamination
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4/3/2018
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2:50 PM
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FDA MedWatch RSS Feed
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Salmonella can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.
Full Article
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Pasta De Lassar Andromaco Skin Protectant 25 Percent Zinc Oxide by MarcasUSA: Recall - Potential Contamination
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4/2/2018
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5:40 PM
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FDA MedWatch RSS Feed
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Use of the contaminated product could result in an increased risk of infection.
Full Article
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Eclipse Kratom by Tamarack: Recall - Possible Salmonella Contamination
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3/26/2018
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2:30 PM
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FDA MedWatch RSS Feed
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Salmonella can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.
Full Article
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BD Vacutainer Blood Collection Tubes by Becton, Dickinson and Company (BD): Class I Recall - Chemical Interference with Certain Tests
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3/23/2018
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3:10 PM
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FDA MedWatch RSS Feed
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Falsely lower test results may lead to improper patient management and treatment for lead exposure or poisoning.
Full Article
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NeuroBlate Probe by Monteris Medical: Letter to Health Care Providers, Class I Recall - Unintended Heating
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3/22/2018
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2:15 PM
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FDA MedWatch RSS Feed
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Instances of unintended heating and damage to the probe, which may have resulted in unintended damage to surrounding brain tissue.
Full Article
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Alka-Seltzer Plus Products: Recall - Ingredients on Front Sticker May Not Match Product in Carton
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3/16/2018
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5:00 PM
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FDA MedWatch RSS Feed
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Consumers may ingest a product to which they may have an allergy or anaphylactic reaction, an ingredient which may be contraindicated for their condition or they intend to otherwise avoid, with potential for serious health consequences.
Full Article
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Neurovascular Embolization Coils: Healthcare Provider Letter - Potential for Increased Image Artifact When Using Magnetic Resonance Angiography For Follow-Up
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3/12/2018
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4:15 PM
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FDA MedWatch RSS Feed
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Reduced quality of MRA image from increased artifact can result in inaccurate clinical diagnoses (e.g., occlusion status) and subsequent inappropriate medical decisions.
Full Article
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Kratom-containing Powder Products by PDX Aromatics: Recall - Potential for Contamination with Salmonella
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3/12/2018
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3:00 PM
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FDA MedWatch RSS Feed
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Salmonella contamination can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.
Full Article
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Methylprednisolone Sodium Succinate for Injection 40mg, 125mg, and 1g by Sagent Pharmaceuticals: Recall - High Out of Specification Impurity Results
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3/6/2018
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5:00 AM
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FDA MedWatch RSS Feed
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An elevated impurity has the potential to decrease effectiveness of the product in patients. Posted: 03/06/2018
Full Article
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Hydromorphone HCL Injection USP by Hospira: Recall - Potential For Empty Or Cracked Glass Vials
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3/5/2018
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7:45 PM
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FDA MedWatch RSS Feed
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Use of or exposure to cracked units may be associated with adverse events such as sharps injury to healthcare professionals.
Full Article
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Compounded Drug Products from Cantrell Drug Company: FDA Warning - Serious Deficiencies in Quality and Sterility Assurance
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3/2/2018
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12:00 PM
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FDA MedWatch RSS Feed
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Administration of contaminated or otherwise poor quality drug products can result in serious and life-threatening injury or death.
Full Article
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Bella Diet Capsules by Bella All Natural: Recall - Presence of Sibutramine
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2/27/2018
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1:00 PM
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FDA MedWatch RSS Feed
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Sibutramine and its active metabolites substantially increase blood pressure and/or pulse rate in some patients and may present significant health risks including heart attack, arrhythmia, and stroke.
Full Article
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Cardiac Resynchronization Therapy with Defibrillation (CRT-Ds) and Implantable Cardiovert-Defibrillators (ICDs) by Medtronic: Class I Recall- Manufacturing Error Preventing Electrical Shock Delivery
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2/27/2018
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12:00 PM
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FDA MedWatch RSS Feed
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Delay or inability to deliver a shock to a patient in cardiac arrest or pace a patient?s heart whose heartbeat is too slow could result in serious injury and/or death.
Full Article
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Labetalol Hydrochloride Injection by Hospira: Recall - Potential For Cracked Glass At Rim Surface Of Vials
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2/23/2018
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8:00 PM
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FDA MedWatch RSS Feed
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Cracked vials may result in a lack of sterility assurance. Use of or exposure to a non-sterile product may be associated with adverse events such as fever, chills, sepsis or invasive systemic infections in patients.
Full Article
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Clarithromycin (Biaxin): Drug Safety Communication - Potential Increased Risk of Heart Problems or Death in Patients With Heart Disease
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2/22/2018
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2:40 PM
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FDA MedWatch RSS Feed
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Prescribers advised to consider using other antibiotics in patients with heart disease.
Full Article
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Acyclovir 400mg Tablets by Apace Packaging: Recall - Product Mix-up
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2/13/2018
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10:00 PM
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FDA MedWatch RSS Feed
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Missing a dose of Acyclovir Tablets could cause a reactivation of a virus being treated.
Full Article
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HeartStart MRx Defibrillator by Philips Electronics: Class I Recall - Defects in Gas Discharge Tubes May Cause Device Failure
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2/9/2018
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4:00 PM
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FDA MedWatch RSS Feed
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Continued use of the device in AED mode after failure may lead to serious patient injury or death.
Full Article
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Pentax Medical Duodenoscope Model ED-3490TK: FDA Safety Communication - Updated Design and Labeling Cleared
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2/7/2018
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4:00 PM
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FDA MedWatch RSS Feed
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Design changes are intended to reduce the potential for leakage of patient fluids into the closed elevator channel and under the distal cap.
Full Article
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Extracorporeal Photopheresis (ECP) Treatment : Letter to Health Care Providers - Death and Pulmonary Embolism
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2/6/2018
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12:00 AM
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FDA MedWatch RSS Feed
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FDA has received seven reports of patients experiencing PE during, or soon after, a treatment.
Full Article
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Gericare Eye Wash by Kareway Products: Recall - Potential Product Contamination
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2/2/2018
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1:30 PM
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FDA MedWatch RSS Feed
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Probability of a potentially sight threatening eye infection or impairment.
Full Article
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Ocaliva (obeticholic acid): Drug Safety Communication - Boxed Warning Added To Highlight Correct Dosing
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2/1/2018
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2:00 PM
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FDA MedWatch RSS Feed
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FDA is clarifying the current recommendations for screening, dosing, monitoring, and managing PBC patients with moderate to severe liver disease taking Ocaliva.
Full Article
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AirLife Humidification Chamber, Heated Breathing Circuit Kits by Vyaire Medical: Class I Recall - Manufacturing Error
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1/31/2018
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1:00 PM
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FDA MedWatch RSS Feed
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Parts of the chamber may split apart into layers, allowing water to overflow the chamber and back up into the patient breathing circuit, which could lead to serious adverse health consequences, including injury or death.
Full Article
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Imodium (loperamide) for Over-the-Counter Use: Drug Safety Communication - FDA Limits Packaging To Encourage Safe Use
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1/30/2018
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2:00 PM
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FDA MedWatch RSS Feed
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Reports of serious heart problems and deaths with much higher than recommended doses of loperamide. FDA working with manufacturers to use blister packs or other single dose packaging and to limit number of doses in a package.
Full Article
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Arthri-D 120ct Dietary Supplement by Arthri-D: Recall - Possible Salmonella Contamination
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1/24/2018
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2:00 PM
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FDA MedWatch RSS Feed
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Salmonella can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.
Full Article
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"Zero For Him" Dietary Supplement by Break Ventures/California Basics: Recall - Possible Salmonella Contamination
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1/24/2018
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2:00 PM
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FDA MedWatch RSS Feed
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Salmonella can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.
Full Article
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Multiple Drug Products by Flawless Beauty: Recall - Misbranded or Unapproved
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1/22/2018
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5:00 AM
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FDA MedWatch RSS Feed
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Misbranded or unapproved new drugs present serious public health risks. Posted 01/22/2018
Full Article
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Basic Drugs Brand of Senna Laxative by Magno-Humphries Laboratories: Recall - Mislabeling
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1/22/2018
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5:00 AM
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FDA MedWatch RSS Feed
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Unintentional consumption of naproxen sodium potentially could result in fatal adverse events in patients with underlying illnesses. Posted 01/22/2018
Full Article
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Levofloxacin in 5 Percent Dextrose 250mg/50mL by AuroMedics: Recall - Presence of Visible Particulate Matter
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1/18/2018
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7:00 PM
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FDA MedWatch RSS Feed
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Use of a non-sterile injectable product could result in fatal infections.
Full Article
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Zoll LifeVest 4000 Wearable Cardioverter Defibrillator: FDA Safety Communication - Potential Lack of Treatment (Shock) Delivery Due to Device Failure
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1/17/2018
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2:40 PM
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FDA MedWatch RSS Feed
|
Failure to immediately replace the device after Message Code 102 appears may result in serious patient harm or death of the patient because the device may fail to deliver therapy when needed.
Full Article
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Varubi (rolapitant) Injectable Emulsion: Health Care Provider Letter - Anaphylaxis and Other Serious Hypersensitivity Reactions
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1/16/2018
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3:40 PM
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FDA MedWatch RSS Feed
|
Symptoms of anaphylaxis can include wheezing or difficulty breathing; swelling of the face or throat; hives or flushing; itching; abdominal cramping, abdominal pain or vomiting; back pain or chest pain; hypotension or shock.
Full Article
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Becton-Dickinson (BD) Syringes Used to Store Compounded or Repackaged Drugs: FDA Alert - Problematic Rubber Stoppers Replaced
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1/12/2018
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6:30 PM
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FDA MedWatch RSS Feed
|
eneral use BD syringes are cleared for immediate use in fluid aspiration and injection, but not for use as a closed container storage system for drug products.
Full Article
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Certitude Delivery System by Edwards Lifesciences: Class I Recall - Mold Overflow Defect Which May Obstruct Blood Flow
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1/11/2018
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4:30 PM
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FDA MedWatch RSS Feed
|
An embolism could obstruct blood flow to critical organs, leading to serious injury and/or a need to surgically extract the overflow material from the patient. Severe neurologic, cardiac, limb, renal, or gastrointestinal injury may result.
Full Article
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Feeding Tube Placement Systems: Letter to Health Care Providers - Reports of Pneumothorax Events
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1/11/2018
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2:00 PM
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FDA MedWatch RSS Feed
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Reported pulmonary events required urgent intervention, including needle decompression or chest tube placement. Several of these events were associated with cardiopulmonary arrest and patient death.
Full Article
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Prescription Opioid Cough and Cold Medicines: Drug Safety Communication - FDA Requires Labeling Changes
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1/11/2018
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1:00 PM
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FDA MedWatch RSS Feed
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Risks of slowed or difficult breathing, misuse, abuse, addiction, overdose, and death with these medicines outweigh their benefits in patients younger than 18.
Full Article
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Clopidogrel Tablets USP, 75 mg by International Laboratories: Recall - Product Mislabeling
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1/11/2018
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12:00 AM
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FDA MedWatch RSS Feed
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Missed doses of Clopidogrel increases the risk of heart attack and stroke which can be life threatening.
Full Article
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Ampicillin and Sulbactam for Injection USP 1.5 g/vial by Auromedics: Recall - Presence of Glass Particles in Vial
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1/4/2018
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1:10 PM
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FDA MedWatch RSS Feed
|
Administration of glass particulate may result in local irritation or swelling in response to the foreign material. More serious potential outcomes would include blockage and clotting in blood vessels, which may be life-threatening.
Full Article
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Compounded Sterile Products by PharMEDium Services: Recall - Lack of Sterility Assurance
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1/2/2018
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7:30 PM
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FDA MedWatch RSS Feed
|
Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening.
Full Article
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Reprocessed Agilis Steerable Introducer Sheath by Sterilmed: Class I Recall - Improper Seal of Sheath Hub
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1/2/2018
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5:00 PM
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FDA MedWatch RSS Feed
|
Improper seals can allow blood to leak through the hub, cause the cap to fall off during the procedure, or can create a difference in pressure that allows air into the circulatory system (air embolism).
Full Article
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Linezolid Injection by Auromedics Pharma: Voluntary Recall 600mg/300mL flexible bags- Due to Presence White Particle Matter That Has Been Identified as Mold
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12/26/2017
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5:00 AM
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FDA MedWatch RSS Feed
|
AuroMedics Pharma is voluntarily recalling one lot of Linezolid Injection 600mg/300mL flexible bags, NDC 55150 -242 -51 batch CLZ160007 expiration August 2018 to the hospital level. This batch was distributed May 15 through August 14, 2017. The product was found to contain white particulate matter that has been identified as mold.
Full Article
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Long-Acting Beta agonists (LABAs) and Inhaled Corticosteroids (ICS): Drug Safety Communication - Boxed Warning About Asthma-Related Death Removed
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12/20/2017
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11:00 PM
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FDA MedWatch RSS Feed
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FDA review of clinical safety trials shows that treating asthma with LABAs in combination with ICS does not result in significantly more serious asthma-related side effects than treatment with ICS alone.
Full Article
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Pantoprazole Sodium for Injection 40 Mg Per Vial: Recall - Presence of Glass Particles
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12/20/2017
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12:30 PM
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FDA MedWatch RSS Feed
|
Administration of a glass particulate may result in local irritation or swelling in response to the foreign material. More serious potential outcomes would include blockage and clotting in blood vessels, which may be life-threatening.
Full Article
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Defibrillation Electrodes for Lifepak AEDs by Physio-Control: Class I Recall - Incorrect Placement Instructions for Infants Depicted on Artwork
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12/19/2017
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8:30 PM
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FDA MedWatch RSS Feed
|
Incorrect placement of electrodes on an infant may result in failure to deliver an effective shock. A delay in therapy could result in serious injury and/or death.
Full Article
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Gadolinium-based Contrast Agents (GBCAs): Drug Safety Communication - Retained in Body; New Class Warnings
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12/19/2017
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1:00 PM
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FDA MedWatch RSS Feed
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Trace amounts of gadolinium may stay in the body long-term.
Full Article
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Blue Pearl All Natural Male Enhancement Supplement: Recall - Undeclared Drug Ingredient
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12/14/2017
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1:00 PM
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FDA MedWatch RSS Feed
|
Undeclared sildenafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels.
Full Article
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Pharmacist Choice Alcohol Prep Pads by Simple Diagnostics: Recall - Lack of Sterility Assurance and Other Quality Issues
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12/5/2017
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3:00 PM
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FDA MedWatch RSS Feed
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The use of impacted alcohol prep pads could result in adverse events such as infections.
Full Article
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Albumin Human 25 Percent Solution (AlbuRx 25): Product Information Advisory - Fading Print On Label
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12/1/2017
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1:30 PM
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FDA MedWatch RSS Feed
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Potential for fading print, with more effect on the expiration dating on the patient tear off portion of the vial label.
Full Article
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Bull Capsules, Chao Jimengnan Tablets by Nutra Labs: Recall - Undeclared Drug Ingredients
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12/1/2017
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1:10 PM
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FDA MedWatch RSS Feed
|
Undeclared sildenafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may cause a significant drop in blood pressure that may be life threatening.
Full Article
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Biotin (Vitamin B7): Safety Communication - May Interfere with Lab Tests
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11/28/2017
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2:00 PM
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FDA MedWatch RSS Feed
|
Biotin in patient samples can cause falsely high or falsely low results, depending on the test. Incorrect test results may lead to inappropriate patient management or misdiagnosis.
Full Article
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Riomet (Metformin Hydrochloride Oral Solution): Recall - Microbial Contamination
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11/27/2017
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3:10 PM
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FDA MedWatch RSS Feed
|
Use of the affected product potentially could result in a risk of infection, especially in an immunocompromised patient.
Full Article
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Limbrel Capsules by Primus Pharmaceuticals: FDA Advisory - Linked to Potentially Life-Threatening Health Problems
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11/21/2017
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5:00 AM
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FDA MedWatch RSS Feed
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Anyone who is currently taking Limbrel may be at risk for developing symptoms associated with drug-induced liver injury and/or hypersensitivity pneumonitis. Posted 11/21/2017
Full Article
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Diphenoxylate Hydrochloride and Atropine Sulfate Tablets by Greenstone: Recall - Possible Sub Potent and Super Potent Tablets
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11/17/2017
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5:00 AM
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FDA MedWatch RSS Feed
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The use of this product in patients with uncontrolled diarrhea due to chronic medical conditions may predispose the patient to toxicity from either the diphenoxylate or atropine components. Posted 11/17/2017
Full Article
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Nexterone (amiodarone HCl) 150 mg/100 mL Premixed Injection: Recall - Presence Of Particulate Matter
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11/15/2017
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6:20 PM
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FDA MedWatch RSS Feed
|
Intravenous administration of a solution containing sterile particulate matter may lead to adverse health consequences.
Full Article
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Febuxostat (Brand Name Uloric): Drug Safety Communication - FDA to Evaluate Increased Risk of Heart-related Death
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11/15/2017
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4:00 PM
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FDA MedWatch RSS Feed
|
Preliminary safety trial results in over 6,000 patients with gout being evaluated.
Full Article
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Injectable Silicone for Body Contouring and Enhancement: FDA Safety Communication - FDA Warns Against Use
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11/14/2017
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3:00 PM
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FDA MedWatch RSS Feed
|
Silicone, when injected into areas with many blood vessels, can travel to other parts of the body and block blood vessels in the lungs, heart, or brain. This can result in permanent damage to those tissues and lead to stroke or death.
Full Article
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Compounded Glutamine, Arginine, and Carnitine Product for Injection by United Pharmacy: Compounding Risk Alert - FDA Investigates Two Adverse Events
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11/8/2017
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8:00 PM
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FDA MedWatch RSS Feed
|
Parenteral drugs, including compounded injectable drugs, with a high pH may lead to skin damage or other unintended health consequences.
Full Article
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Infant/Child Reduced Energy Defibrillation Electrodes by Cardinal Health: Voluntary Field Action - Incorrect Artwork on Packaging
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11/6/2017
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1:30 PM
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FDA MedWatch RSS Feed
|
If the user incorrectly places the defibrillation electrodes, it may result in ineffective energy delivery to the patient and serious injury or death.
Full Article
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Ridge Properties DBA Pain Relief Naturally Products: Recall - Manufacturing Concerns at the Facility
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11/6/2017
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1:00 PM
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FDA MedWatch RSS Feed
|
Risk of decreased quality and consistency (i.e., the safety, identity, strength, quality and purity)
Full Article
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Octagam [Immune Globulin Intravenous (human)] 10 Percent Liquid Preparation]: Voluntary Market Withdrawal
|
10/23/2017
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|
12:00 PM
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FDA MedWatch RSS Feed
|
Suspend further administration of octagam 10% from production lots K724B8541 and K725A8541.
Full Article
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Injectable Products by SCA Pharmaceuticals: Recall - Potential Contamination
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10/21/2017
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4:00 AM
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FDA MedWatch RSS Feed
|
Administration of a drug product, intended to be sterile, that may contain microbial contamination has the potential to result in serious adverse events which may include life-threatening infections. Posted 10/21/2017
Full Article
|
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Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) by St. Jude Medical: FDA Safety Communication - Batteries May Fail Earlier Than Expected
|
10/19/2017
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7:30 PM
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FDA MedWatch RSS Feed
|
UPDATED 10/19/2017. St. Jude Medical notified physicians of the Battery Performance Alert (BPA), a new tool that detects and notifies physicians of abnormal battery performance that may lead to premature battery depletion.
Full Article
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A1 Slim by Kiriko: Recall - Undeclared Drug Ingredients
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10/7/2017
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4:00 AM
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FDA MedWatch RSS Feed
|
Product tainted with sibutramine, phenolphthalein and N-Desmethyl sibutramine.
Full Article
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Intralipid 20 Percent IV Fat Emulsion by Baxter: Recall - One Shipment of Product Exposed to Subfreezing Temperatures
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10/6/2017
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3:00 PM
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FDA MedWatch RSS Feed
|
When subjected to freezing, emulsion droplets will increase in size, forming aggregates that can block pulmonary circulation/lead to serious adverse health consequences that can be life-threatening.
Full Article
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Intraocular Injections of a Compounded Triamcinolone, Moxifloxacin, and Vancomycin (TMV) Formulation: FDA Statement - Case of Hemorrhagic Occlusive Retinal Vasculitis
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10/3/2017
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7:00 PM
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FDA MedWatch RSS Feed
|
Prophylactic use of intraocular vancomycin, alone or in a compounded drug, during cataract surgery is generally not recommended because of the risk of HORV.
Full Article
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Infant Sleep Positioners: FDA Warning - Risk of Suffocation
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10/3/2017
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2:00 PM
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FDA MedWatch RSS Feed
|
FDA reminding parents and caregivers not to put babies in sleep positioners. These products, sometimes also called ?nests? or ?anti-roll? products, can cause suffocation that can lead to death.
Full Article
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Endovascular Graft Systems: Letter to Health Care Providers - Type III Endoleaks Associated with Use
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9/28/2017
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3:00 PM
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FDA MedWatch RSS Feed
|
Type III endoleak may require treatment with additional interventions such as re-lining, insertion of additional endograft components, or open surgical repair. Interventions to address endoleaks carry added risks for impacted patients.
Full Article
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Bridge Occlusion Balloon Catheter Model 590-001 by Spectranetics: Class I Recall - Clinical Issue
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9/25/2017
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|
10:30 PM
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FDA MedWatch RSS Feed
|
If device with blocked guidewire lumen were used, device would not be positioned correctly and hemorrhage would not be controlled, delaying life-saving treatment, which may result in serious adverse health consequences, including death.
Full Article
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TAH-t Companion 2 Driver System (C2) and Freedom Driver System by SynCardia Systems: Letter to Health Care Providers - Mortality and Neurological Adverse Event Results
|
9/25/2017
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5:30 PM
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FDA MedWatch RSS Feed
|
UPDATED 09/25/2017. Most recent interim results from the ongoing SynCardia TAH-t post-approval study looking at mortality and neurological adverse events.
Full Article
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Vegetable Vigra by Natures Supplement: Recall - Undeclared Drug Ingredient
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9/21/2017
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|
5:00 PM
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FDA MedWatch RSS Feed
|
Men with diabetes, high blood pressure, high cholesterol, or heart disease, may be on medications that, taken with this product, could lower blood pressure to dangerous levels that could be life-threatening.
Full Article
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Ocaliva (obeticholic acid): Drug Safety Communication - Increased Risk of Serious Liver Injury
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9/21/2017
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2:00 PM
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FDA MedWatch RSS Feed
|
Reports of Ocaliva being incorrectly dosed in some patients with moderate to severe decreases in liver function. Some patients received a higher frequency of dosing than is recommended in the drug label.
Full Article
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Rhino 7, Papa Zen, Fifty Shades, and Grande X Dietary Supplements by Gadget Island: Recall - Undeclared Drug Ingredients
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9/20/2017
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|
9:41 PM
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FDA MedWatch RSS Feed
|
Use of products with undeclared active ingredients sildenafil, tadalafil and desmethyl carbodenafil may interact with nitrates and may cause a significant drop in blood pressure that may be life threatening.
Full Article
|
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Opioid Addiction Medications in Patients Taking Benzodiazepines or CNS Depressants: Drug Safety Communication - Careful Medication Management Can Reduce Risks
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9/20/2017
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4:00 PM
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FDA MedWatch RSS Feed
|
Health care professionals should develop a treatment plan when buprenorphine or methadone is used in combination with benzodiazepines or other CNS depressants.
Full Article
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Urogynecologic Surgical Mesh Implants by Boston Scientific: Notification ? Potential for Counterfeit Raw Material
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9/19/2017
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|
4:00 AM
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FDA MedWatch RSS Feed
|
UPDATED 09/19/2017 Updating after extensive review of data and information.
Full Article
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OriGen VV28F Reinforced Dual Lumen ECMO Catheters: Recall - Potential for Separation of Extension Tube From Hub
|
9/13/2017
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6:00 PM
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FDA MedWatch RSS Feed
|
Separation could result in required intervention to prevent permanent impairment/damage.
Full Article
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Diabetes Infusion Sets by Medtronic: Recall - Vent Membrane May be Susceptible to Being Blocked by Fluid
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9/12/2017
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4:00 AM
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FDA MedWatch RSS Feed
|
May lead to potential over-delivery of insulin shortly after an infusion set change, which may cause hypoglycemia. Posted 09/12/2017
Full Article
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Baby Organic Liquid Formula by Garden of Life: Recall - Directions For Use May Be Misinterpreted
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9/8/2017
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|
6:00 PM
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FDA MedWatch RSS Feed
|
If not administered precisely following the labeled instructions, the product may present difficulties in swallowing and potentially pose a choking hazard due to the thickness of the liquid.
Full Article
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Activase (alteplase) 100mg by Genentech: Recall - Lack of Sterility Assurance
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9/7/2017
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|
4:00 AM
|
FDA MedWatch RSS Feed
|
The use of impacted Sterile Water for Injection could result in adverse events such as fever, chills, phlebitis, and granuloma or more severe adverse events such as sepsis or invasive systemic infections.
Full Article
|
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Intra-Aortic Balloon Pumps by Datascope/MAQUET: Class I Recall - False Blood Detection Alarm, Ingress of Fluid Into Pump
|
9/6/2017
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|
5:00 PM
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FDA MedWatch RSS Feed
|
If therapy is stopped during use without a replacement IABP available, device failure may result in immediate and serious adverse health consequences, including death.
Full Article
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Kayexalate (sodium polystyrene sulfonate): Drug Safety Communication - FDA Recommends Separating Dosing
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9/6/2017
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|
1:00 PM
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FDA MedWatch RSS Feed
|
Too much potassium in the blood can cause problems with heart rhythm, which in rare cases can be fatal.
Full Article
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Hydromorphone HCl Injection, USP 2 mg/mL, and Levophed (Norepinephrine Bitartrate Injection, USP) 4 mg/4 mL (1 mg/mL) Vial by Hospira: Recall - Lack of Sterility Assurance
|
9/5/2017
|
|
7:00 PM
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FDA MedWatch RSS Feed
|
If impacted product is administered to a patient, adverse events ranging from fever, chills, and malaise, to severe adverse events such as septicemia, bacterial meningitides and wound infection could occur.
Full Article
|
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Unexpired Lots of Oxytocin Compounded with Either Lactated Ringers or Lactated Ringers and Dextrose by PharMEDium - Recall - Sub-Potency
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9/1/2017
|
|
4:00 AM
|
FDA MedWatch RSS Feed
|
An extreme and unexpected reduction in dose than expected could lead to a delay in treatment, disruption of clinical care of the patient, and worsening of patient's conditions.
Full Article
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Alcohol Pads or Benzalkonium Chloride Antiseptic Towelettes by Foshan Flying Medical Products: FDA Alert - Lack of Sterility Assurance and Other Quality Issues
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9/1/2017
|
|
4:00 AM
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FDA MedWatch RSS Feed
|
The use of these alcohol pads and antiseptic towelettes could cause infections.
Full Article
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Keytruda (pembrolizumab) in Patients with Multiple Myeloma: FDA Statement - Two Clinical Trials on Hold
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8/31/2017
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3:00 PM
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FDA MedWatch RSS Feed
|
Risks associated with the use of Keytruda in combination with dexamethasone and an immunomodulatory agent (lenalidomide or pomalidomide) for the treatment of patients with multiple myeloma.
Full Article
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Vancomycin Hydrochloride for Injection, USP, 750 mg/vial by Hospira: Recall - Presence of Particulate Matter
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8/31/2017
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|
12:00 PM
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FDA MedWatch RSS Feed
|
If administered to a patient, particulate may result in phlebitis, end-organ granuloma or micro-embolic effects, or gastrointestinal trauma.
Full Article
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Doctor Manzanilla Cough & Cold and Doctor Manzanilla Allergy & Decongestant Relief Syrup: Recall - Potential Contamination with Burkholderia cepacia
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8/30/2017
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|
11:00 PM
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FDA MedWatch RSS Feed
|
Contaminated products with Burkholderia cepacia can potentially result in serious infections, may be life-threating in patients with compromised immune systems.
Full Article
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Piyanping Anti-Itch Lotion: Recall - Incorrect Active Ingredient
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8/30/2017
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|
10:00 PM
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FDA MedWatch RSS Feed
|
There is a reasonable probability of the following side effects of topical steroids which include but are not limited to skin changes, adrenal suppression, glaucoma, and cataracts.
Full Article
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Forced Air Thermal Regulating Systems: Healthcare Provider Letter - Information About Use
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8/30/2017
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|
3:00 PM
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FDA MedWatch RSS Feed
|
FDA continues to recommend the use of thermoregulating devices (including forced air thermal regulating systems) for surgical procedures when clinically warranted.
Full Article
|
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Implantable Cardiac Pacemakers by Abbott (formerly St. Jude Medical): Safety Communication - Firmware Update to Address Cybersecurity Vulnerabilities
|
8/29/2017
|
|
5:00 PM
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FDA MedWatch RSS Feed
|
Vulnerabilities, if exploited, could allow an unauthorized user to access patient's device, which could result in patient harm from rapid battery depletion or administration of inappropriate pacing.
Full Article
|
|
Zenith Alpha Thoracic Endovascular Graft by Cook Medical: Recall Correction and Removal of Specific Sizes from Market - Increased Reports of Graft Thrombosis and Occlusion in BTAI Treatment
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8/28/2017
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|
4:00 AM
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FDA MedWatch RSS Feed
|
Correction removed the indication for BTAI; Voluntary recall includes Zenith Alpha Thoracic products in sizes of 18-22mm, including the 26-22mm tapered device.
Full Article
|
|
Ninjacof and Ninjacof A: Recall - Potential Burkholderia Cepacia Contamination
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8/23/2017
|
|
4:15 PM
|
FDA MedWatch RSS Feed
|
Use of a product that may contain B. cepacia could result in infections in patients with compromised immune systems and in patients with chronic lung conditions such as cystic fibrosis.
Full Article
|
|
Sterile Drug Products by Bella Pharmaceuticals: Recall - Lack of Sterility Assurance
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8/18/2017
|
|
7:30 PM
|
FDA MedWatch RSS Feed
|
Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening.
Full Article
|
|
Zenith Alpha Thoracic Endovascular Graft by Cook Medical: Class I Recall - Potential Formation of Thrombus Inside Device
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8/16/2017
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|
4:00 PM
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FDA MedWatch RSS Feed
|
Thrombus may form inside the device after implantation. Thrombosis or occlusion may lead to serious adverse health consequences, including death.
Full Article
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Lorazepam Oral Concentrate, USP 2mg/mL by Amneal Pharmaceuticals: Recall - Misprinted Dosing Droppers
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8/16/2017
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|
11:00 AM
|
FDA MedWatch RSS Feed
|
Significant probability of serious health consequences if more than the prescribed dose is dispensed, including: drowsiness causing trauma; increased anxiety; and risk of accidental injury to self or others.
Full Article
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|
Pravastatin Sodium Tablets by International Laboratories: Recall - Mislabeling
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8/10/2017
|
|
8:00 PM
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FDA MedWatch RSS Feed
|
Common side effects of bupropion include: nausea, vomiting, dry mouth, headache, constipation, sweating, sore throat, diarrhea, dizziness, restlessness, blurry vision. Risk of allergic reactions are possible and could be life threatening.
Full Article
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Liquid Products Manufactured by PharmaTech and Distributed by Leader Brand, Major Pharmaceuticals, and Rugby Laboratories: Recall - Possible Product Contamination
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8/10/2017
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|
7:45 PM
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FDA MedWatch RSS Feed
|
Reports of B. cepacia infections in patients.
Full Article
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Liquid-filled Intragastric Balloon Systems: Letter to Healthcare Providers - Potential Risks
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8/10/2017
|
|
3:00 PM
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FDA MedWatch RSS Feed
|
Five reports of unanticipated deaths that occurred from 2016 to present, in patients with liquid-filled intragastric balloon systems used to treat obesity.
Full Article
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Sterile Drug Products from Vital Rx, dba Atlantic Pharmacy and Compounding: FDA Alert - Lack of Sterility Assurance
|
8/10/2017
|
|
3:00 PM
|
FDA MedWatch RSS Feed
|
Administration of a non-sterile product intended to be sterile may result in serious and potentially life threatening infections or death.
Full Article
|
|
Liquid Drug Products Manufactured by PharmaTech and Distributed by Rugby Laboratories and Possibly Other Companies: FDA Advisory - Not to Use
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8/8/2017
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|
4:00 AM
|
FDA MedWatch RSS Feed
|
Advisory due to Burkholderia cepacia contamination and the potential for severe patient infection.
Full Article
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Balguti Kesaria Ayurvedic Medicine: FDA Warning - High Levels Of Lead
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8/4/2017
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|
9:25 PM
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FDA MedWatch RSS Feed
|
Exposure to lead can cause serious damage to the central nervous system, the kidneys and the immune system.
Full Article
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Compounded Curcumin Emulsion Product for Injection by ImprimisRx: FDA Investigation - Serious Adverse Events Associated with Use
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8/4/2017
|
|
3:30 PM
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FDA MedWatch RSS Feed
|
Drug products, including FDA-approved products, containing polyethylene glycol castor oil have been associated with severe and sometimes fatal hypersensitivity reactions.
Full Article
|
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Diocto Liquid and Diocto Syrup by Rugby Laboratories: Recall - Possible Product Contamination
|
8/3/2017
|
|
5:10 PM
|
FDA MedWatch RSS Feed
|
Use could result in serious or life-threatening infections in patients with compromised immune systems and in patients with chronic lung conditions such as cystic fibrosis.
Full Article
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Man of Steel 1 and Man of Steel 2: Recall - Undeclared Drug Ingredient
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7/31/2017
|
|
5:20 PM
|
FDA MedWatch RSS Feed
|
Use of product found to contained undeclared Sildenafil could result in death. The groups affected include men with diabetes, high blood pressure, high cholesterol, or heart disease.
Full Article
|
|
0.9 Percent Sodium Chloride Injection by ICU Medical: Recall - Presence of Particulate Matter
|
7/31/2017
|
|
4:00 PM
|
FDA MedWatch RSS Feed
|
Injection of particulate matter could potentially lead to limited adverse events such as allergic reactions, local irritation and inflammation in organs or tissues, or other serious adverse health consequences.
Full Article
|
|
Compounded Triamicinolone and Moxifloxacin Product for Intravitreal Injection by Guardian Pharmacy Services: Alert to Health Professionals - Serious Adverse Events Reported
|
7/28/2017
|
|
8:20 PM
|
FDA MedWatch RSS Feed
|
Patients had diminished visual function and adverse reactions after injection into the vitreous of the eye at the end of the cataract surgery procedure.
Full Article
|
|
Cyclobenzaprine HCl and Amantadine HCl by Apace Packaging: Recall - Potential Mislabeling
|
7/28/2017
|
|
2:45 PM
|
FDA MedWatch RSS Feed
|
Unintentional dosing with Cyclobenzaprine HCl may potentially lead to the development of life-threatening serotonin syndrome, and other serious adverse events.
Full Article
|
|
Sterile Drug Products by Cantrell Drug Company: Recall - Lack of Sterility Assurance
|
7/25/2017
|
|
10:44 PM
|
FDA MedWatch RSS Feed
|
Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening.
Full Article
|
|
La Bri's Body Health Atomic and Xplode Capsules by EZ Weight Loss TX: Recall - Undeclared Drug Ingredient
|
7/25/2017
|
|
7:00 PM
|
FDA MedWatch RSS Feed
|
Sibutramine is known to increase blood pressure and/or pulse rate in some patients and may present a risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.
Full Article
|
|
Super Panther 7K by Ultra Shop Supplement: Recall - Undeclared Drug Ingredients
|
7/24/2017
|
|
2:30 PM
|
FDA MedWatch RSS Feed
|
Consumers with diabetes, hypertension, high cholesterol or heart disease often take nitrates; concomitant use of nitrates and PDE-5 can lead to fatal cardiovascular collapse.
Full Article
|
|
Penumbra 3D Revascularization Device by Penumbra: Class I Recall - Wire Material May Break or Separate During Use
|
7/21/2017
|
|
3:25 PM
|
FDA MedWatch RSS Feed
|
Fractured pieces of the delivery wire could be left inside the patient?s brain bloodstream. This or the attempts made to retrieve the fractured pieces can lead to serious adverse health consequences.
Full Article
|
|
ED-530XT Duodenoscopes by Fujifilm: Safety Communication - Recall Issued, Updated Design and Labeling
|
7/21/2017
|
|
3:00 PM
|
FDA MedWatch RSS Feed
|
Fujifilm issued an Urgent Medical Device Correction and Removal notification, informing customers of its voluntary recall of all ED-530XT duodenoscopes.
Full Article
|
|
Sten Z and M1 Alpha Capsules by Andropharm: Recall - Contains Derivatives of Anabolic Steroids
|
7/12/2017
|
|
6:33 PM
|
FDA MedWatch RSS Feed
|
Consumption of these products may cause elevated blood pressure, aggressive behavior, male infertility, or enlarged breasts and shrinkage of the testes in men.
Full Article
|
|
Novopen Echo Insulin Delivery Device by Novo Nordisk: Recall - May Crack or Break If Exposed To Certain Chemicals
|
7/6/2017
|
|
6:30 PM
|
FDA MedWatch RSS Feed
|
Using a device with a cracked/broken cartridge holder may result in the device delivering a reduced dose of insulin which could potentially lead to high blood sugar.
Full Article
|
|
Vascu-Guard Peripheral Vascular Patch by Baxter International: Letter to Health Care Providers - Potential Risk of Severe Bleeding and Hematomas
|
7/6/2017
|
|
6:00 PM
|
FDA MedWatch RSS Feed
|
UPDATED 07/06/2017. Voluntary recall closed on June 23, 2017. FDA continues to recommend that health care providers discuss with their patients all available treatment options for CEA surgery.
Full Article
|
|
Ultra-Sten and D-Zine Capsules by Hardcore Formulations: Recall - Contains Anabolic Steroids
|
7/6/2017
|
|
1:00 PM
|
FDA MedWatch RSS Feed
|
Consumption of products containing derivatives of anabolic steroids may cause serious liver injury and other adverse health consequences, including kidney injury, increased risk of heart attack and stroke.
Full Article
|
|
Atar Extension Cables by Oscor: Recall - Cable Separating from Connector
|
7/6/2017
|
|
4:00 AM
|
FDA MedWatch RSS Feed
|
For pacing dependent patients, an interruption of pacing system could result in serious injury or death if not detected. Posted 07/06/2017
Full Article
|
|
Potassium Phosphate and Succinylcholine Chloride by PharMEDium Services: Recall - Lack of Sterility Assurance
|
6/27/2017
|
|
4:00 AM
|
FDA MedWatch RSS Feed
|
Reasonable probability that the patient may experience adverse events ranging from fever, chills and malaise, to severe adverse events including systemic invasive mycoses or systemic bacterial sepsis.
Full Article
|
|
ADM Animal Nutrition Recalls Rough-N-Ready Cattle Feed A specific lot of product contains elevated levels of monensin, could harm cattle
|
6/23/2017
|
|
11:31 PM
|
FDA Pet Health RSS Feed
|
ADM Animal Nutrition, a division of Archer Daniels Midland Company (NYSE: ADM), is recalling 50-pound bags of Rough-N-Ready 14 BT cattle feed, product number 54787BHB24, because the product contains elevated levels of monensin beyond the recommended dosage, which could be harmful to cattle. At elevated levels, monensin can be toxic to cattle and can cause colic-like symptoms, hypokalemia, myoglobinuria, chronic cardiovascular issues, and possible death.
Full Article
|
|
Succinylcholine Chloride 20mg/mL 5mL Syringe by Fagron Sterile Services: Recall - Potential Lack Of Sterility Assurance
|
6/23/2017
|
|
7:30 PM
|
FDA MedWatch RSS Feed
|
Reasonable probability that patient may experience adverse events ranging from fever, chills and malaise, to severe adverse events including systemic invasive mycoses or systemic bacterial sepsis.
Full Article
|
|
Potassium Phosphate and Succinylcholine by Advanced Pharma: Recall - Potential Lack of Sterility Assurance
|
6/22/2017
|
|
7:20 PM
|
FDA MedWatch RSS Feed
|
Patient may experience adverse events ranging from fever, chills and malaise, to severe adverse events including systemic invasive mycoses or systemic bacterial sepsis.
Full Article
|
|
Venture Catheters by Vascular Solutions: Recall - Excess Material May Split or Separate During Use
|
6/21/2017
|
|
6:00 PM
|
FDA MedWatch RSS Feed
|
Material in the patient's bloodstream can result in serious adverse health consequences such as the development of blood clots, embolism of the excess material to vital organs, or death.
Full Article
|
|
System CS100, CS100i and CS300 Intra-Aortic Balloon Pumps by Datascope: Field Correction - Potential Electrical Test Failure Code
|
6/19/2017
|
|
2:15 PM
|
FDA MedWatch RSS Feed
|
Risk of failure of the device to initiate therapy.
Full Article
|
|
Clindamycin Injection ADD-Vantage Vials by Alvogen: Recall - Lack of Sterility Assurance
|
6/17/2017
|
|
2:00 AM
|
FDA MedWatch RSS Feed
|
There is a reasonable probability that the patient may experience adverse events, ranging from fever, chills and malaise, to severe adverse events including systemic invasive mycoses or systemic bacterial sepsis.
Full Article
|
|
United Pet Group Expands Voluntary Recall of Multiple Brands of Rawhide Chew Products for Dogs to Also Include Private Label Brands Due to Possible Chemical Contamination
|
6/17/2017
|
|
12:12 AM
|
FDA Pet Health RSS Feed
|
United Pet
Group, a division of Spectrum Brands, Inc. is voluntarily expanding its recall of multiple brands of packages of rawhide dog chew products to include our retail partners? private label brands. The recall involves the brands and products described below.
Full Article
|
|
Frameless Stereotaxic Navigation Systems: FDA Safety Communication - Navigational Accuracy Errors
|
6/15/2017
|
|
4:00 AM
|
FDA MedWatch RSS Feed
|
Accuracy errors may lead to patient deaths, serious or life-threatening injuries, and inaccurate, aborted, or prolonged medical procedures Posted 06/15/2017
Full Article
|
|
Unexpired Nitroglycerin Injection in 5 Percent Dextrose USP by Advanced Pharma in Houston: Recall - Sub Potency
|
6/15/2017
|
|
4:00 AM
|
FDA MedWatch RSS Feed
|
An extreme and unexpected reduction in dose than expected could lead to a delay in treatment, disruption of clinical care of the patient, and worsening of patient?s conditions. Posted 06/15/2017
Full Article
|
|
Paliperidone Extended-Release Tablets 3mg by Teva Pharmaceuticals: Recall - Dissolution Test Failure
|
6/15/2017
|
|
4:00 AM
|
FDA MedWatch RSS Feed
|
Failed dissolution could result in less drug being absorbed. Posted 06/15/2017
Full Article
|
|
Sodium Bicarbonate Injection 8.4 Percent USP, Neut (Sodium Bicarbonate 4 Percent Additive Solution), Quelicin (Succinylcholine Chloride Injection USP), and Potassium Phosphates Injection by Hospira: Recall - Potential For Lack Of Sterility Assurance
|
6/15/2017
|
|
4:00 AM
|
FDA MedWatch RSS Feed
|
A patient may experience adverse events ranging from fever, chills and malaise, to severe adverse events including systemic invasive mycoses or systemic bacterial sepsis. Posted 06/16/2017
Full Article
|
|
Loving Pets Voluntarily Recalls Limited Lot Numbers of Air-Puffed Dog Treats Because of Possible Salmonella Health Risk
|
6/14/2017
|
|
9:26 PM
|
FDA Pet Health RSS Feed
|
Loving Pets of Cranbury, NJ is voluntarily recalling a limited number of dog treats because of the potential to be contaminated with Salmonella.
Salmonella can affect animals eating the products and there is risk to humans from handling contaminated pet products, especially if they have not thoroughly washed their hands after having contact with the
products or any surfaces exposed to these products.
Full Article
|
|
Topical Products by Phillips Company: Recall - Due to Concerns of Manufacturing Practices
|
6/14/2017
|
|
7:42 PM
|
FDA MedWatch RSS Feed
|
The possibility of decreased quality and consistency of the product, may have an impact on the safety and efficacy of the product posing a risk to patients.
Full Article
|
|
Eliquis (apixaban) 5 mg tablets: Recall One Lot- Bottle labeled as Eliquis 5 mg was found to contain Eliquis 2.5 mg tablets
|
6/13/2017
|
|
6:50 PM
|
FDA MedWatch RSS Feed
|
Patients should not stop taking Eliquis without consulting with their physician
Full Article
|
|
United Pet Group Voluntary Recalls Multiple Brands of Rawhide Chew Products for Dogs Due to Possible Chemical Contamination
|
6/10/2017
|
|
8:41 PM
|
FDA Pet Health RSS Feed
|
United Pet
Group, a division of Spectrum Brands, Inc. is voluntarily recalling multiple brands of packages of rawhide dog chew products that were distributed to retail outlets and sold online in the U.S. The recall involves the brands and products described below.
Full Article
|
|
SpF PLUS-Mini and SpF XL IIB Implantable Spinal Fusion Stimulators by Zimmer Biomet: Class I Recall - Potential for Harmful Chemicals
|
5/30/2017
|
|
5:00 PM
|
FDA MedWatch RSS Feed
|
Higher than allowed levels of harmful chemicals may cause chronic infections, long-term hospitalization due to additional surgical procedures, paralysis, and death. Posted 05/30/2017
Full Article
|
|
Mibela 24 Fe Chewable Tablets by Lupin Pharmaceuticals Inc.: Recall - Out of Sequence Tablets and Missing Expiry/Lot Information
|
5/29/2017
|
|
11:25 PM
|
FDA MedWatch RSS Feed
|
Oral contraceptive tablets that are taken out of sequence may place the user at risk for contraceptive failure and unintended pregnancy.
Full Article
|
|
Brilinta (ticagrelor) 90 mg tablets, 8-count Physician Sample Bottles: Recall of Lot # JB5047 - Due to Report of Another Medicine in One Bottle
|
5/26/2017
|
|
2:39 PM
|
FDA MedWatch RSS Feed
|
Unintentional dosing with Zurampic has the potential to lead to adverse renal effects including acute renal failure.
Full Article
|
|
Caverflo Natural Herbal Coffee: Recall - Presence of Undeclared Active Pharmaceutical Ingredients
|
5/26/2017
|
|
12:19 PM
|
FDA MedWatch RSS Feed
|
Presence of sildenafil and tadalafil may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels.
Full Article
|
|
Al-Er-G Capsules by MusclMasster: Recall - Contains Banned Substance Ephedra
|
5/25/2017
|
|
12:20 PM
|
FDA MedWatch RSS Feed
|
Dietary supplements containing ephedrine alkaloids pose a risk of serious adverse events, including heart attack, stroke, and death.
Full Article
|
|
HeartMate II LVAS Pocket System Controller by Abbott-Thoratec: Class I Recall - Due to Risk of Patient Injury and/or Death during Backup Controller Exchange
|
5/23/2017
|
|
9:06 PM
|
FDA MedWatch RSS Feed
|
A slow or improper driveline changeover places certain patients at risk of serious injury or death.
Full Article
|
|
Tri-Ton by Dynamic Technical Formulations, LLC: Recall - Contains Andarine and Ostarine Drug Ingredients
|
5/22/2017
|
|
6:50 PM
|
FDA MedWatch RSS Feed
|
Use or consumption of products containing SARMs and anabolic steroid-like substances may cause acute liver injury, which is known to be a possible harmful effect of using steroid containing products.
Full Article
|
|
V60 Non-invasive Ventilator by Respironics: Class I Recall - Unexpected Device Shut Down
|
5/22/2017
|
|
5:30 PM
|
FDA MedWatch RSS Feed
|
Unexpected stop in ventilation therapy may cause serious adverse health consequences, including death.
Full Article
|
|
Gadolinium-based Contrast Agents for Magnetic Resonance Imaging (MRI): Drug Safety Communication - No Harmful Effects Identified With Brain Retention
|
5/22/2017
|
|
1:00 PM
|
FDA MedWatch RSS Feed
|
Health care professionals should continue to limit GBCA use to circumstances in which additional information provided by the contrast agent is necessary, and assess the necessity of repetitive MRIs with GBCAs.
Full Article
|
|
LeadCare Testing Systems (with Blood Obtained from a Vein) by Magellan Diagnostics: FDA Safety Communication - Risk of Inaccurate Results
|
5/17/2017
|
|
1:20 PM
|
FDA MedWatch RSS Feed
|
Falsely lower test results may lead to improper patient management and treatment for lead exposure or poisoning.
Full Article
|
|
Coronary Catheters by Abbott: Recall - Difficulty in Removing Balloon Sheath
|
5/16/2017
|
|
3:00 PM
|
FDA MedWatch RSS Feed
|
Potential risks associated with balloon inflation and deflation difficulties include air embolism, additional intervention, thrombosis, and myocardial infarction.
Full Article
|
|
Canagliflozin (Invokana, Invokamet): Drug Safety Communication - Increased Risk of Leg and Foot Amputations
|
5/16/2017
|
|
1:00 PM
|
FDA MedWatch RSS Feed
|
New warnings, including a Boxed Warning, to be added to the canagliflozin drug labels.
Full Article
|
|
Phenobarbital 15 mg Tablets, USP by C.O. Truxton: Recall - Labeling Error on Declared Strength
|
5/8/2017
|
|
7:30 PM
|
FDA MedWatch RSS Feed
|
UPDATED 5/8/2017. C.O. Truxton expands their 04/21/2017 recall to include additional products.
Full Article
|
|
C.O. Truxton, Inc. Issues Voluntary Nationwide Recall of Amitriptyline HCL Tablets, USP 50mg and Phenobarbital Tablets, USP 15mg, 30mg, 60mg, 100mg Due to Potential Label Mix-Up
|
5/8/2017
|
|
7:15 PM
|
FDA Pet Health RSS Feed
|
Bellmawr, New Jersey, C.O. Truxton, Inc. is expanding their 04/21/2017 voluntary recall, as a precaution to include the following C.O. Truxton, Inc. products, registered NDC numbers and corresponding lot numbers, to the consumer/user level. C.O. Truxton has not received any complaints for the products listed below. however, due to the initial recall resulting from a label mix-up error, out of an abundance of caution, we are recalling all products that were repackaged into a Truxton Incorporated label.
Full Article
|
|
GEC Laxoplex Dietary Supplement Capsules by Genetic Edge Compounds: Recall - Presence of Anabolic Steroids
|
5/8/2017
|
|
12:15 PM
|
FDA MedWatch RSS Feed
|
Use or consumption of products containing anabolic steroids may cause acute liver injury. Abuse of anabolic steroids may cause other serious long-term adverse health consequences in men, women, and children.
Full Article
|
|
HeartWare Splice Kit Intended to Repair the Driveline of its Ventricular Assist Device by Medtronic: Recall - May Cause Electrical Issues or Pump Stops
|
5/5/2017
|
|
6:10 PM
|
FDA MedWatch RSS Feed
|
An interruption in electrical connection may cause the pump to stop, which may lead to serious adverse health consequences, including death.
Full Article
|
|
Ventricular Assist Device Controllers and DC Adapter by Medtronic Mechanical Circulatory Support (formerly HeartWare Inc.): Class I Recall - Updated Controller, Power Management Software
|
5/4/2017
|
|
5:30 PM
|
FDA MedWatch RSS Feed
|
Loose connector may allow moisture to enter controller causing corrosion, electrical issues, reduced speaker volume and connection failures which could cause serious adverse health consequences, including death.
Full Article
|
|
Wingman35 Crossing Catheters by ReFlow Medical: Recall - Tip Splitting or Separation
|
5/3/2017
|
|
7:00 PM
|
FDA MedWatch RSS Feed
|
Tip splitting has the potential to lead to loss of device function. Tip separation may require medical intervention to retrieve a separated segment or may occlude blood flow to end organs.
Full Article
|
|
NavLock Tracker by Medtronic: Letter to Healthcare Providers - Patient Injuries Reported
|
5/3/2017
|
|
1:55 PM
|
FDA MedWatch RSS Feed
|
Minor and serious injuries, including two patient deaths, following procedures that involved the use of non-Medtronic instruments with Medtronic's NavLock Tracker.
Full Article
|
|
Newport HT70 and HT70 Plus Ventilators by Medtronic: Field Corrective Action - Ventilator May Reset Spontaneously
|
5/2/2017
|
|
7:01 PM
|
FDA MedWatch RSS Feed
|
UPDATED 05/02/2017. Class I Recall. Potential for ventilator reset during normal operation, without an accompanying alarm.
Full Article
|
|
General Anesthetic and Sedation Drugs: Drug Safety Communication - FDA Approves Label Changes for Use in Young Children
|
4/27/2017
|
|
5:15 PM
|
FDA MedWatch RSS Feed
|
Exposure to these medicines for lengthy periods of time or over multiple surgeries or procedures may negatively affect brain development in children younger than 3 years.
Full Article
|
|
Illegal Cancer Treatments: FDA Warning - Fraudulent Claims of Diagnosis, Treatment, Prevention or Cure
|
4/25/2017
|
|
1:25 PM
|
FDA MedWatch RSS Feed
|
Use of unproven or unapproved products may be unsafe and could prevent a person from seeking an appropriate and potentially life-saving cancer diagnosis or treatment.
Full Article
|
|
Party Animal Recalls Dog Food Due To Potential Presence of Pentobarbital
|
4/25/2017
|
|
12:01 AM
|
FDA Pet Health RSS Feed
|
On April 13, a retailer in Texas notified us that
their customer had presented samples of our 13-ounce-can Cocolicious Beef & Turkey
dog food (Lot #0136E15204 04, best by July 2019) and 13-ounce-can Cocolicious
Chicken & Beef dog food (Lot #0134E15 237 13, best by August 2019) to a testing lab,
and that the results had tested positive for pentobarbital.
Full Article
|
|
25 Percent Dextrose Injection, USP (Infant) by Hospira: Recall - Particulate Matter
|
4/24/2017
|
|
2:05 PM
|
FDA MedWatch RSS Feed
|
Particulate administered to a patient could result in local swelling, irritation of blood vessels or tissue, blockage of blood vessels and/or systemic allergic response to the particulate.
Full Article
|
|
C.O. Truxton, Inc. Issues Voluntary Nationwide Recall of Phenobarbital 15 mg Tablets, USP due to Labeling Error on Declared Strength
|
4/21/2017
|
|
4:52 PM
|
FDA Pet Health RSS Feed
|
Bellmawr, New Jersey, C.O. Truxton, Inc. is voluntarily recalling lot 70952A of Phenobarbital Tablets, USP, 15 mg, to the consumer/user level. The manufacturer received a confirmed customer complaint that a bottle labeled as phenobarbital 15 mg was found to contain phenobarbital 30 mg tablets.
Full Article
|
|
Codeine and Tramadol Medicines: Drug Safety Communication - Restricting Use in Children, Recommending Against Use in Breastfeeding Women
|
4/20/2017
|
|
3:30 PM
|
FDA MedWatch RSS Feed
|
New and strengthened WARNINGS and CONTRAINDICATIONS on drug labels describing serious risks, including slowed or difficult breathing and death.
Full Article
|
|
Organic Herbal Supply Supplement Products: Recall - Undeclared Drug Ingredients
|
4/19/2017
|
|
12:55 PM
|
FDA MedWatch RSS Feed
|
Use of these products may pose a threat to consumers because the undeclared ingredients may interact with nitrates found in some prescription drugs and may lower blood pressure to dangerous levels.
Full Article
|
|
StrataMR Adjustable Valves and Shunts by Medtronic: Recall - Potential for Under-Drainage of Cerebrospinal Fluid
|
4/9/2017
|
|
1:29 AM
|
FDA MedWatch RSS Feed
|
If left untreated, under-drainage can potentially lead to coma and death.
Full Article
|
|
Sterile Compounded Products by Isomeric Pharmacy Solutions: Recall - Lack of Sterility Assurance
|
4/6/2017
|
|
8:35 PM
|
FDA MedWatch RSS Feed
|
Voluntary recall of all lots of sterile products, to the hospital/user level.
Full Article
|
|
EpiPen and EpiPen Jr Auto-Injector: Recall - Failure to Activate Device
|
3/31/2017
|
|
11:00 PM
|
FDA MedWatch RSS Feed
|
Failure to activate or increased force needed to activate may have significant health consequences for a patient experiencing a life-threatening allergic reaction (anaphylaxis).
Full Article
|
|
Prelude Short Sheath Introducer by Merit Medical Systems: Class I Recall - Sheath May Separate During Use
|
3/31/2017
|
|
5:30 PM
|
FDA MedWatch RSS Feed
|
Tip could enter the patient's bloodstream, resulting in prolonged procedure times, additional surgery to remove the tip from the patient, blood clots, internal tears and perforation to arteries or veins, excessive bleeding, and death.
Full Article
|
|
LaBri’s Body Health Atomic by Envy Me: Recall - Undeclared Drug Ingredient
|
3/30/2017
|
|
1:50 PM
|
FDA MedWatch RSS Feed
|
Sibutramine may substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.
Full Article
|
|
Breast Implants: Update - Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)
|
3/21/2017
|
|
5:00 PM
|
FDA MedWatch RSS Feed
|
BIA-ALCL is a rare condition; when it occurs, it has been identified most frequently in patients undergoing implant revision operations for late onset, persistent seroma.
Full Article
|
|
EuroCan Manufacturing Voluntarily Recalling Barnsdale Farms? Pig Ears Because of Possible Salmonella Health Risk
|
3/20/2017
|
|
10:47 PM
|
FDA Pet Health RSS Feed
|
(March 20, 2017) New Hamburg, Ontario - EuroCan Manufacturing is voluntarily recalling Lot
Number 84 consisting of it's individually shrink-wrapped, 6-pack, 12-pack and 25-pack bags of
Barnsdale Farms?, HoundsTooth? and Mac's Choice? Pig Ears because they have the potential to be
contaminated with Salmonella. Salmonella can affect animals eating the products and there is a risk to
humans from handling contaminated pet products, especially if they have not thoroughly washed their
hands after having contact with the products or any surfaces exposed to these products.
Full Article
|
|
Absorb GT1 Bioresorbable Vascular Scaffold (BVS) by Abbott Vascular: Letter to Health Care Providers - FDA Investigating Increased Rate of Major Adverse Cardiac Events
|
3/18/2017
|
|
2:00 PM
|
FDA MedWatch RSS Feed
|
Increased rate of major adverse cardiac events observed in patients receiving the BVS, when compared to patients treated with metallic XIENCE drug-eluting stent.
Full Article
|
|
Blue Buffalo Voluntarily Recalls One Lot of BLUE Wilderness? Rocky Mountain Recipe TM Red Meat Dinner Wet Food For Adult DogsDue to Potential Health Risk
|
3/18/2017
|
|
2:27 AM
|
FDA Pet Health RSS Feed
|
Blue Buffalo Company is voluntarily recalling one production lot of BLUE Wilderness? Rocky Mountain RecipeTM Red Meat Dinner Wet Food for Adult Dogs, as the product has the potential to contain elevated levels of naturally- occurring beef thyroid hormones.
Full Article
|
|
Wellpet Voluntarily Recalls a Limited Amount of One Recipe of Canned Topper For Dogs Due to Potential Elevated Levels of Naturally Occurring Beef Thyroid Hormone
|
3/18/2017
|
|
1:19 AM
|
FDA Pet Health RSS Feed
|
WellPet has initiated a voluntary recall of a limited amount of one canned topper product due to potential elevated levels of naturally occurring beef thyroid hormone.
Full Article
|
|
Wellpet Voluntarily Recalls a Limited Amount of One Recipe of Canned Topper For Dogs Due to Potential Elevated Levels of Naturally Occurring Beef Thyroid Hormone
|
3/18/2017
|
|
1:19 AM
|
FDA Pet Health RSS Feed
|
WellPet has initiated a voluntary recall of a limited amount of one canned topper product due to potential elevated levels of naturally occurring beef thyroid hormone.
Full Article
|
|
Viberzi (eluxadoline): Drug Safety Communication - Increased Risk of Serious Pancreatitis In Patients Without A Gallbladder
|
3/15/2017
|
|
4:02 PM
|
FDA MedWatch RSS Feed
|
Patients who do not have a gallbladder should not take Viberzi. Developing pancreatitis could result in hospitalization or death.
Full Article
|
|
Viberzi (eluxadoline): Drug Safety Communication - Increased Risk of Serious Pancreatitis In Patients Without A Gallbladder
|
3/15/2017
|
|
4:02 PM
|
FDA MedWatch RSS Feed
|
Patients who do not have a gallbladder should not take Viberzi. Developing pancreatitis could result in hospitalization or death.
Full Article
|
|
SynchroMed II and SynchroMed EL Implantable Drug Infusion Pumps by Medtronic: Class I Recall - Failure of Priming Bolus
|
3/14/2017
|
|
5:20 PM
|
FDA MedWatch RSS Feed
|
Patients may receive a drug overdose or under dose which can lead to serious adverse health consequences such as respiratory depression, coma or death.
Full Article
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SynchroMed II and SynchroMed EL Implantable Drug Infusion Pumps by Medtronic: Class I Recall - Failure of Priming Bolus
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3/14/2017
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5:20 PM
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FDA MedWatch RSS Feed
|
Patients may receive a drug overdose or under dose which can lead to serious adverse health consequences such as respiratory depression, coma or death.
Full Article
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Lifepak 1000 Defibrillators by Physio-Control: Voluntary Field Action - Immediately Remove and Reinstall Battery
|
3/9/2017
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7:23 PM
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FDA MedWatch RSS Feed
|
Device has shut down unexpectedly during patient treatment, which may expose patients to the risk of serious harm or death. Posted 01/14/2017
Full Article
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Herbal and Dietary Supplement Products by Regeneca Worldwide: Recall - Not Manufactured in Compliance with Current Good Manufacturing Practices
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3/9/2017
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6:40 PM
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FDA MedWatch RSS Feed
|
Nationwide recall of Regeneca's entire line of herbal and dietary supplement products.
Full Article
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Herbal and Dietary Supplement Products by Regeneca Worldwide: Recall - Not Manufactured in Compliance with Current Good Manufacturing Practices
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3/9/2017
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6:40 PM
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FDA MedWatch RSS Feed
|
Nationwide recall of Regeneca's entire line of herbal and dietary supplement products.
Full Article
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SPS-1 Static Preservation Solution distributed by Organ Recovery Systems: Safety Communication - FDA Warns Of Potential Contamination
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3/9/2017
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4:00 PM
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FDA MedWatch RSS Feed
|
Laboratory results confirmed contamination with Pantoea and Enterococcus (intrinsically vancomycin-resistant) bacteria.
Full Article
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SPS-1 Static Preservation Solution distributed by Organ Recovery Systems: Safety Communication - FDA Warns Of Potential Contamination
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3/9/2017
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4:00 PM
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FDA MedWatch RSS Feed
|
Laboratory results confirmed contamination with Pantoea and Enterococcus (intrinsically vancomycin-resistant) bacteria.
Full Article
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Balloon angioplasty devices to treat autonomic dysfunction: FDA Safety Communication - FDA concern over experimental procedures
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3/8/2017
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6:30 PM
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FDA MedWatch RSS Feed
|
Procedure may put patients at risk because is being promoted as treatment for a variety of conditions even though it has not been formally studied in clinical trials
Full Article
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Balloon angioplasty devices to treat autonomic dysfunction: FDA Safety Communication - FDA concern over experimental procedures
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3/8/2017
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6:30 PM
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FDA MedWatch RSS Feed
|
Procedure may put patients at risk because is being promoted as treatment for a variety of conditions even though it has not been formally studied in clinical trials
Full Article
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Dietary Supplements for Male Sexual Enhancement by A and H Focal: Recall - Undeclared Drug Ingredient
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3/8/2017
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1:00 AM
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FDA MedWatch RSS Feed
|
PDE-5 Inhibitors may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels.
Full Article
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Dietary Supplements for Male Sexual Enhancement by A and H Focal: Recall - Undeclared Drug Ingredient
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3/8/2017
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1:00 AM
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FDA MedWatch RSS Feed
|
PDE-5 Inhibitors may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels.
Full Article
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Evanger?s Pet Food and Against the Grain Voluntarily Recalls Additional Products Out of Abundance of Caution due to Potential Adulteration with Pentobarbital
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3/4/2017
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4:04 PM
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FDA Pet Health RSS Feed
|
Out of an abundance of caution, Evanger's Dog & Cat Food is voluntarily expanding its recall of Hunk of Beef and is also recalling Evanger's Braised Beef and Against the Grain?s Pulled Beef Products due to potential adulteration with pentobarbital.?Oral exposure to pentobarbital can cause drowsiness, dizziness, excitement, loss of balance, nausea, nystagmus (eyes moving back and forth in a jerky manner), inability to stand, coma and death. Consumers who notice these symptoms in their pets should consult their veterinarian.
Full Article
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Evanger?s Pet Food and Against the Grain Voluntarily Recalls Additional Products Out of Abundance of Caution due to Potential Adulteration with Pentobarbital
|
3/4/2017
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|
4:04 PM
|
FDA Pet Health RSS Feed
|
Out of an abundance of caution, Evanger's Dog & Cat Food is voluntarily expanding its recall of Hunk of Beef and is also recalling Evanger's Braised Beef and Against the Grain?s Pulled Beef Products due to potential adulteration with pentobarbital.?Oral exposure to pentobarbital can cause drowsiness, dizziness, excitement, loss of balance, nausea, nystagmus (eyes moving back and forth in a jerky manner), inability to stand, coma and death. Consumers who notice these symptoms in their pets should consult their veterinarian.
Full Article
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Edex (alprostadil for injection) 10 mcg 2 Pack by Endo Pharmaceuticals: Recall - Potential Lack of Sterility Assurance
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2/27/2017
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6:00 PM
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FDA MedWatch RSS Feed
|
Loss of container closure integrity could impact the product?s sterility assurance and may lead to serious adverse events such as infections, both localized at the site of injection and systemically.
Full Article
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Edex (alprostadil for injection) 10 mcg 2 Pack by Endo Pharmaceuticals: Recall - Potential Lack of Sterility Assurance
|
2/27/2017
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|
6:00 PM
|
FDA MedWatch RSS Feed
|
Loss of container closure integrity could impact the product’s sterility assurance and may lead to serious adverse events such as infections, both localized at the site of injection and systemically.
Full Article
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Avella Specialty Pharmacy Unexpired Sterile Injectable Products Labeled “Latex Free”: Recall - Products May Contain Synthetic or Natural Latex
|
2/25/2017
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|
1:00 AM
|
FDA MedWatch RSS Feed
|
Risk of potential adverse events can range from local site reactions including swelling and inflammation, to allergic reactions which could be life-threatening to users who are sensitive to latex.
Full Article
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Avella Specialty Pharmacy Unexpired Sterile Injectable Products Labeled ?Latex Free?: Recall - Products May Contain Synthetic or Natural Latex
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2/25/2017
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|
1:00 AM
|
FDA MedWatch RSS Feed
|
Risk of potential adverse events can range from local site reactions including swelling and inflammation, to allergic reactions which could be life-threatening to users who are sensitive to latex.
Full Article
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XtraHRD Natural Male Enhancement Capsules by Organic Herbal Supply, Inc.: Recall - Undeclared Drug Ingredient
|
2/22/2017
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|
1:00 PM
|
FDA MedWatch RSS Feed
|
Undeclared tadalafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels.
Full Article
|
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XtraHRD Natural Male Enhancement Capsules by Organic Herbal Supply, Inc.: Recall - Undeclared Drug Ingredient
|
2/22/2017
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|
1:00 PM
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FDA MedWatch RSS Feed
|
Undeclared tadalafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels.
Full Article
|
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Comprehensive Reverse Shoulder by Zimmer Biomet: Class I Recall - High Fracture Rate
|
2/16/2017
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2:30 PM
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FDA MedWatch RSS Feed
|
Fractures may result in revision surgeries which could cause serious adverse health consequences such as permanent loss of shoulder function, infection, or rarely, death.
Full Article
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Comprehensive Reverse Shoulder by Zimmer Biomet: Class I Recall - High Fracture Rate
|
2/16/2017
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|
2:30 PM
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FDA MedWatch RSS Feed
|
Fractures may result in revision surgeries which could cause serious adverse health consequences such as permanent loss of shoulder function, infection, or rarely, death.
Full Article
|
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HCG (Human Chorionic Gonadotropin) Freeze Dried Vials by Synergy Rx: Recall - Lack of Sterility Assurance
|
2/15/2017
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|
1:30 PM
|
FDA MedWatch RSS Feed
|
Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening.
Full Article
|
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HCG (Human Chorionic Gonadotropin) Freeze Dried Vials by Synergy Rx: Recall - Lack of Sterility Assurance
|
2/15/2017
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|
1:30 PM
|
FDA MedWatch RSS Feed
|
Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening.
Full Article
|
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Against The Grain Pet Food Voluntarily Recalls One Lot of Pulled Beef Due to Potential Adulteration with Pentobarbital
|
2/15/2017
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|
12:33 AM
|
FDA Pet Health RSS Feed
|
Out of an abundance of caution, Against the Grain Pet Food is voluntarily recalling one lot of Against the Grain Pulled Beef with Gravy Dinner for Dogs that was manufactured and distributed in 2015. The 12 oz. Against the Grain Pulled Beef with Gravy Dinner for Dogs that is being voluntarily recalled, due to the potential presence of pentobarbital, has an expiration date of December 2019, a lot number of 2415E01ATB12, and the second half of the UPC code is 80001 (which can be found on the back of the product label).
Full Article
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PetSmart Voluntarily Recalls Single Lot of Grreat Choice? Canned Dog Food Due to Possible Health Risk
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2/10/2017
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|
7:56 PM
|
FDA Pet Health RSS Feed
|
PetSmart has issued a voluntary recall of one production lot of its Grreat Choice? Adult Dog Food sold on PetSmart.com, Pet360.com, PetFoodDirect.com and in nationwide PetSmart retail stores. This product is being voluntarily recalled as a precautionary measure due to metal contamination that could potentially be a choking hazard to pets.
Full Article
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Alaris Syringe Pump Module (Large Volume Pump), Model 8100 and AIL Sensor Kits by CareFusion: Class I Recall - Alarm Error
|
2/9/2017
|
|
4:00 PM
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FDA MedWatch RSS Feed
|
Faulty Air-In-Line sensor which may generate a false alarm, and cause the syringe pump to stop supplying the infusion to the patient. Interruption of infusion could lead to serious adverse health consequences or death.
Full Article
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Alaris Syringe Pump Module (Large Volume Pump), Model 8100 and AIL Sensor Kits by CareFusion: Class I Recall - Alarm Error
|
2/9/2017
|
|
4:00 PM
|
FDA MedWatch RSS Feed
|
Faulty Air-In-Line sensor which may generate a false alarm, and cause the syringe pump to stop supplying the infusion to the patient. Interruption of infusion could lead to serious adverse health consequences or death.
Full Article
|
|
Ibuprofen Lysine Injection, 20 mg /2 mL (10 mg/mL) by Exela Pharma Sciences: Recall - Particulate Matter
|
2/9/2017
|
|
2:35 PM
|
FDA MedWatch RSS Feed
|
Particulate matter has the potential to block blood vessels, provoke an immune reaction, and/or lead to microinfarcts which could be life threatening.
Full Article
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Ibuprofen Lysine Injection, 20 mg /2 mL (10 mg/mL) by Exela Pharma Sciences: Recall - Particulate Matter
|
2/9/2017
|
|
2:35 PM
|
FDA MedWatch RSS Feed
|
Particulate matter has the potential to block blood vessels, provoke an immune reaction, and/or lead to microinfarcts which could be life threatening.
Full Article
|
|
Well Balance Xanthium & Siler Combo (Bi Yan Pian) Dietary Supplement by Kingsway Trading Inc.: Recall - Product Contains Banned Ephedra Alkaloids
|
2/9/2017
|
|
12:45 PM
|
FDA MedWatch RSS Feed
|
Supplements containing ephedrine alkaloids pose a risk of serious adverse events, including heart attack, stroke, and death.
Full Article
|
|
Well Balance Xanthium & Siler Combo (Bi Yan Pian) Dietary Supplement by Kingsway Trading Inc.: Recall - Product Contains Banned Ephedra Alkaloids
|
2/9/2017
|
|
12:45 PM
|
FDA MedWatch RSS Feed
|
Supplements containing ephedrine alkaloids pose a risk of serious adverse events, including heart attack, stroke, and death.
Full Article
|
|
Evanger?s Voluntarily Recalls Hunk of Beef Because Of Pentobarbital Exposure in one Batch of Food
|
2/3/2017
|
|
10:05 PM
|
FDA Pet Health RSS Feed
|
Out of an abundance of caution, Evanger?s Dog & Cat Food of Wheeling, IL is voluntarily recalling specific lots of its Hunk of Beef product because of a potential contaminant Pentobarbital, which was detected in one lot of Hunk of Beef Au Jus. Pentobarbital can affect animals that ingest it, and possibly cause side effects such as drowsiness, dizziness, excitement, loss of balance, or nausea, or in extreme cases, possibly death.
Full Article
|
|
Chlorhexidine Gluconate: Drug Safety Communication - Rare But Serious Allergic Reactions
|
2/2/2017
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|
6:24 PM
|
FDA MedWatch RSS Feed
|
Reactions can occur within minutes of exposure, and may include wheezing or difficulty breathing; swelling of the face; hives that can quickly progress to more serious symptoms; severe rash; or shock, a life-threatening condition.
Full Article
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Chlorhexidine Gluconate: Drug Safety Communication - Rare But Serious Allergic Reactions
|
2/2/2017
|
|
6:24 PM
|
FDA MedWatch RSS Feed
|
Reactions can occur within minutes of exposure, and may include wheezing or difficulty breathing; swelling of the face; hives that can quickly progress to more serious symptoms; severe rash; or shock, a life-threatening condition.
Full Article
|
|
Halo One Thin-Walled Guiding Sheath by Bard Peripheral Vascular Inc.: Class I Recall - Sheath Separation, Kinking, or Tip Damage
|
1/30/2017
|
|
7:10 PM
|
FDA MedWatch RSS Feed
|
The affected product may cause serious adverse health consequences such as internal tears and perforation to arteries or veins, excessive bleeding, and death.
Full Article
|
|
Halo One Thin-Walled Guiding Sheath by Bard Peripheral Vascular Inc.: Class I Recall - Sheath Separation, Kinking, or Tip Damage
|
1/30/2017
|
|
7:10 PM
|
FDA MedWatch RSS Feed
|
The affected product may cause serious adverse health consequences such as internal tears and perforation to arteries or veins, excessive bleeding, and death.
Full Article
|
|
Certain Homeopathic Teething Products: FDA Warning- Confirmed Elevated Levels of Belladonna
|
1/27/2017
|
|
6:55 PM
|
FDA MedWatch RSS Feed
|
Homeopathic teething products containing belladonna pose an unnecessary risk to infants and children. Posted 01/27/2017
Full Article
|
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Certain Homeopathic Teething Products: FDA Warning- Confirmed Elevated Levels of Belladonna
|
1/27/2017
|
|
6:55 PM
|
FDA MedWatch RSS Feed
|
Homeopathic teething products containing belladonna pose an unnecessary risk to infants and children. Posted 01/27/2017
Full Article
|
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NucliSENS easyMAG Magnetic Silica and NucliSENS Magnetic Extraction Reagents by bioMerieux: Class I Recall - Potential Inaccurate Test Results
|
1/27/2017
|
|
6:15 PM
|
FDA MedWatch RSS Feed
|
Risk of false negative results, invalid results, or under-quantification for clinical laboratory tests. This error may result in inappropriate treatment or delay in treatment.
Full Article
|
|
NucliSENS easyMAG Magnetic Silica and NucliSENS Magnetic Extraction Reagents by bioMerieux: Class I Recall - Potential Inaccurate Test Results
|
1/27/2017
|
|
6:15 PM
|
FDA MedWatch RSS Feed
|
Risk of false negative results, invalid results, or under-quantification for clinical laboratory tests. This error may result in inappropriate treatment or delay in treatment.
Full Article
|
|
Vancomycin Hydrochloride for Injection, USP by Hospira: Recall - Particulate Matter in Vial
|
1/25/2017
|
|
1:00 PM
|
FDA MedWatch RSS Feed
|
Injected particulate may result in local swelling, irritation of blood vessels or tissue, blockage of blood vessels and/or low-level allergic response to the particulate.
Full Article
|
|
ED-3490TK Video Duodenoscope by Pentax: FDA Safety Communication - UPDATE - Follow Pentax Validated Reprocessing Instructions
|
1/17/2017
|
|
3:00 PM
|
FDA MedWatch RSS Feed
|
Updated recommendations to help prevent the spread of infection associated with the use of these devices.
Full Article
|
|
Lifepak 1000 Defibrillators by Physio-Control: Voluntary Field Action - Immediately Remove and Reinstall Battery
|
1/14/2017
|
|
5:00 AM
|
FDA MedWatch RSS Feed
|
Device has shut down unexpectedly during patient treatment, which may expose patients to the risk of serious harm or death. Posted 01/14/2017
Full Article
|
|
Duodenoscopes by Fujifilm Medical Systems: Safety Communication - Certain Older Models Removed From Clinical Use
|
1/13/2017
|
|
4:00 PM
|
FDA MedWatch RSS Feed
|
Fuji removing legacy 250/450 duodenoscope models from clinical use, replacing with with the ED-530XT model.
Full Article
|
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PNC-27 Products: FDA Warning ? Do Not Use For Treatment or Cure for Cancer
|
1/12/2017
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|
2:00 PM
|
FDA MedWatch RSS Feed
|
Consumers who use a contaminated product are at risk for serious, potentially life-threatening infections.
Full Article
|
|
Medrad Intego PET Infusion System Source Administration Sets by Bayer: Corrective Action - Particulates Generated in Vial
|
1/11/2017
|
|
10:30 PM
|
FDA MedWatch RSS Feed
|
The particulate matter could enter into the patient and cause serious adverse health consequences including infection, damage of tissue, and death.
Full Article
|
|
Implantable Infusion Pumps in the Magnetic Resonance (MR) Environment: FDA Safety Communication - Important Safety Precautions
|
1/11/2017
|
|
3:50 PM
|
FDA MedWatch RSS Feed
|
Reports of serious adverse events, including patient injury & death, describing medication dosing inaccuracies and other mechanical problems with pumps after an MRI exam.
Full Article
|
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Implantable Cardiac Devices and Merlin@home Transmitter by St. Jude Medical: FDA Safety Communication - Cybersecurity Vulnerabilities Identified
|
1/9/2017
|
|
5:00 AM
|
FDA MedWatch RSS Feed
|
These vulnerabilities, if exploited, could allow an unauthorized user to remotely access a patient's RF-enabled implanted cardiac device by altering the Merlin@home Transmitter.
Full Article
|
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ZIKV Detect IgM Capture ELISA by InBios International, Inc: FDA Safety Communication - Wait for Confirmatory Test Results Before Making Patient Management Decisions
|
12/23/2016
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|
2:35 PM
|
FDA MedWatch RSS Feed
|
IgM tests remain useful in ruling out Zika exposure, but require confirmatory testing. Do not rely on presumptive positive Zika virus IgM test results as the sole basis of significant patient management decisions.
Full Article
|
|
Standard Offset Cup Impactor with POM-C Handle by Greatbatch Medical: Class I Recall - Inadequate Sterilization
|
12/20/2016
|
|
3:00 PM
|
FDA MedWatch RSS Feed
|
Non-sterile surgical devices can lead to infections, and other serious adverse health consequences, including death.
Full Article
|
|
Chantix (varenicline) and Zyban (bupropion): Drug Safety Communication - Mental Health Side Effects Revised
|
12/16/2016
|
|
5:01 PM
|
FDA MedWatch RSS Feed
|
FDA determined the risk of serious side effects on mood, behavior, or thinking is lower than previously suspected.
Full Article
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|
Ridley Block Operations Announces Voluntary Recall of Ultralyx 24% + 3% Mag Composite
|
12/15/2016
|
|
3:24 PM
|
FDA Pet Health RSS Feed
|
Ridley Block Operations has initiated a voluntary recall of a single batch of its beef cattle feed product, Ultralyx 24% + 3% Mag Composite Block, because it contains elevated levels of non-protein nitrogen (NPN) that may be harmful to beef cattle.
Full Article
|
|
General Anesthetic and Sedation Drugs: Drug Safety Communication - New Warnings for Young Children and Pregnant Women
|
12/14/2016
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|
5:01 PM
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FDA MedWatch RSS Feed
|
Published studies in pregnant animals and young animals have shown the use of general anesthetic and sedation drugs for more than 3 hours caused widespread loss of nerve cells in the brain.
Full Article
|
|
Pioglitazone-containing Medicines: Drug Safety Communication - Updated FDA Review, Increased Risk of Bladder Cancer
|
12/12/2016
|
|
8:05 PM
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FDA MedWatch RSS Feed
|
FDA approved label updates to describe additional studies reviewed.
Full Article
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Convenience Kits containing Multi-Med Single Lumen Catheters by Centurion: Class I Recall - Excess Material May Split or Separate
|
12/9/2016
|
|
8:30 PM
|
FDA MedWatch RSS Feed
|
Excess material may separate from catheter during use and enter patient’s bloodstream, resulting in serious adverse health consequences such as blood clots, embolism of the excess material to vital organs, or death.
Full Article
|
|
Blue Ridge Beef of Eatonton, GA Recalls Product Because of Possible Health Risk
|
12/9/2016
|
|
8:05 PM
|
FDA Pet Health RSS Feed
|
Blue Ridge Beef is voluntarily recalling two (2) of its frozen products due to their potential to be contaminated with salmonella and/or listeria monocytogenes. Salmonella and Listeria can affect animals eating the product. There is a risk to humans from handling contaminated pet products, especially if they have not thoroughly washed their hands after having contact with the products or any surface exposed to these products.
Full Article
|
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Intermountain Farmers Association Issues Recall of Rabbit Feed for High Vitamin D Content
|
12/1/2016
|
|
7:39 PM
|
FDA Pet Health RSS Feed
|
Intermountain Farmers Association (IFA) of Draper, UT, is recalling its 50 lbs. bags of rabbit pellets (item #1220) manufactured between March 14, 2016 and September 15, 2016, because the product may contain higher than acceptable levels of vitamin D, which may cause health problems to rabbits.
Full Article
|
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Megajex Natural Male Sex Enhancer by MS Bionic: Recall - Undeclared Drug Ingredients
|
12/1/2016
|
|
1:40 PM
|
FDA MedWatch RSS Feed
|
Undeclared tadalafil and sildenafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels.
Full Article
|
|
Ultimate Body Tox PRO: Recall - Undeclared Drug Ingredient
|
12/1/2016
|
|
1:15 PM
|
FDA MedWatch RSS Feed
|
Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.
Full Article
|
|
DMAA Net Weight 500g by NutriVitaShop: Recall - Presence of DMAA May Pose Health Risk
|
11/26/2016
|
|
3:00 PM
|
FDA MedWatch RSS Feed
|
DMAA can narrow blood vessels and arteries, which can cause a rise in blood pressure or other cardiovascular problems such as shortness of breath, arrhythmias, tightening in the chest, and heart attack.
Full Article
|
|
Products Containing Belladonna Extract by Raritan Pharmaceuticals: Recall - Possible Belladonna Alkaloids
|
11/25/2016
|
|
5:00 AM
|
FDA MedWatch RSS Feed
|
The homeopathic products have a very small amount of belladonna, a substance that can cause harm at larger doses.
Full Article
|
|
FindrWIRZ Guidewire System by SentreHeart: Class I Recall - Coating Separation
|
11/22/2016
|
|
7:50 PM
|
FDA MedWatch RSS Feed
|
Can lead to serious adverse health consequences including embolism, stroke, or death.
Full Article
|
|
Tri-Coast Pharmacy Sterile Products: Recall - Lack of Sterility Assurance
|
11/21/2016
|
|
8:00 PM
|
FDA MedWatch RSS Feed
|
Administration of a drug product intended to be sterile that has microbial contamination has the potential to result in serious infections which may be life-threatening.
Full Article
|
|
Sterile Drug Products by Cantrell Drug Company: Recall - Lack of Sterility Assurance
|
11/21/2016
|
|
5:30 PM
|
FDA MedWatch RSS Feed
|
Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening.
Full Article
|
|
GNC Women?s Ultra Mega Time Release 180 count Dietary Supplement by Nutra Manufacturing: Recall - Undeclared Milk
|
11/18/2016
|
|
7:00 PM
|
FDA MedWatch RSS Feed
|
People who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction.
Full Article
|
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Essure Permanent Birth Control System by Bayer Healthcare: FDA Announcement - Label Changes
|
11/15/2016
|
|
5:10 PM
|
FDA MedWatch RSS Feed
|
Essure labeling now includes the addition of a boxed warning and a Patient Decision Checklist.
Full Article
|
|
Skinny Bee Diet by Love My Tru Body: Recall - Undeclared Drug Ingredients
|
11/8/2016
|
|
8:50 PM
|
FDA MedWatch RSS Feed
|
Undeclared sibutramine, desmethylsibutramine, and/phenolphthalein present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.
Full Article
|
|
Side Head Regulator TT Tablet by Life Rising/Ton Shen Health: Recall - Elevated Levels of Lead
|
11/8/2016
|
|
2:15 PM
|
FDA MedWatch RSS Feed
|
Acute lead poisoning may cause abdominal pain, muscle weakness, nausea, vomiting, diarrhea, weight loss, and bloody or decreased urinary output. Long term exposure can lead to permanent damage to the central nervous system. Posted 11/08/2016
Full Article
|
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HeartWare Ventricular Assist Device (HVAD) Pumps by HeartWare Inc.: Class I Recall - Loose Connectors May Prevent Alarm from Sounding
|
10/28/2016
|
|
6:45 PM
|
FDA MedWatch RSS Feed
|
Loose power connector may allow moisture to enter the controller causing corrosion, electrical issues, reduced speaker volume and connection failures.
Full Article
|
|
TAH-t Companion 2 Driver System (C2) and Freedom Driver System by SynCardia Systems: Letter to Health Care Providers - Mortality and Neurological Adverse Event Results
|
10/26/2016
|
|
3:00 PM
|
FDA MedWatch RSS Feed
|
The most recent post-approval study results assessing post-market performance is available.
Full Article
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Testosterone and Other Anabolic Androgenic Steroids (AAS): FDA Statement - Risks Associated With Abuse and Dependence
|
10/25/2016
|
|
4:29 PM
|
FDA MedWatch RSS Feed
|
New Warning and updated Abuse and Dependence sections of labeling, including new safety information from published literature and case reports.
Full Article
|
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HeartWare Ventricular Assist Device (HVAD) Pumps by HeartWare Inc.: Class I Recall - Contamination Causing Electrical Issues
|
10/24/2016
|
|
4:00 AM
|
FDA MedWatch RSS Feed
|
Contamination of the driveline may result in fluid or other material entering the pump and causing electrical issues or pump stops that may lead to serious adverse health consequences, including death.
Full Article
|
|
Willy Rusch Tracheostomy Tube Set by TeleFlex Medical: Class I Recall - Possible Disconnection During Patient Use
|
10/20/2016
|
|
6:00 PM
|
FDA MedWatch RSS Feed
|
Connector detachment during use can deprive patient of adequate ventilation and require immediate medical intervention.
Full Article
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Radiation Therapy Devices by Multidata Systems International: Discontinue Use ? Concerns about Risks to Patients
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10/20/2016
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1:30 PM
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FDA MedWatch RSS Feed
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The FDA is concerned that health care providers may be unaware of the risks associated with these devices.
Full Article
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Medtronic Neurovascular Products: Recall - Potential Separation and Detachment of Polytetrafluoroethylene (PTFE) Coating
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10/18/2016
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4:01 PM
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FDA MedWatch RSS Feed
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PTFE in the blood stream, based on the size and quantity, could lead to a thromboembolic event.
Full Article
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Skintact DF29N Multi-function Defibrillation Electrodes by Leonhard Lang: Class I Recall - Connector Compatibility Issue
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10/14/2016
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6:30 PM
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FDA MedWatch RSS Feed
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User may not be able to connect electrodes to Welch Allyn AED model 10 defibrillator, which may result in a delay in delivering the electrical therapy.
Full Article
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St?ckert 3T Heater-Cooler System by LivaNova PLC (formerly Sorin Group Deutschland GmbH): UPDATED Safety Communication - Reports of Mycobacterium Chimaera Infections
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10/13/2016
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7:00 PM
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FDA MedWatch RSS Feed
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New information about M. chimaera infections, and updated recommendations to help prevent the spread of infection.
Full Article
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Mars Petcare US Announces Voluntary Recall of Limited Number of CESAR® Classics Filet Mignon Flavor Wet Dog Food Because of Potential Presence of Plastic
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10/11/2016
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2:44 PM
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FDA Pet Health RSS Feed
|
Today, Mars Petcare US of Franklin, Tennessee, announced a voluntary recall of a limited number of CESAR Classics Filet Mignon Flavor product due to a potential choking risk from hard white pieces of plastic which entered the food during the production process. CESAR Classics Filet Mignon can be purchased individually, as well as, in flavor variety multipacks.
Full Article
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Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) by St. Jude Medical: FDA Safety Communication - Batteries May Fail Earlier Than Expected
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10/11/2016
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2:20 PM
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FDA MedWatch RSS Feed
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In some cases full battery drainage can occur within a day to a few weeks after patient receives ERI alert. If battery runs out, ICD or CRT-D will be unable to deliver life-saving pacing or shocks, which could lead to patient death.
Full Article
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I.V. Flush Syringes by Nurse Assist: Recall - Potential Link to Burkholderia Cepacia Bloodstream Infections
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10/5/2016
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5:50 PM
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FDA MedWatch RSS Feed
|
The effects of Burkholderia cepacia on people vary widely, ranging from no symptoms at all to serious respiratory infections, especially in patients with cystic fibrosis.
Full Article
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Twin-Pass Dual Access Catheters by Vascular Solutions: Recall - Potential for Excess Manufacturing Material At The Tip
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10/5/2016
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5:50 PM
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FDA MedWatch RSS Feed
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Excess material may separate from the catheter during use and pose a potential risk of embolism, which could result in serious injury or death.
Full Article
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Direct-Acting Antivirals for Hepatitis C: Drug Safety Communication - Risk of Hepatitis B Reactivating
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10/4/2016
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5:40 PM
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FDA MedWatch RSS Feed
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FDA requiring a Boxed Warning about the risk of HBV reactivation to be added to drug labels, directing health care professionals to screen and monitor for HBV in all patients receiving DAA treatment.
Full Article
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50mm 0.2 Micron Filters by Baxter: Recall - Potential for Missing Filter Support Membrane, Particulate Matter
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10/3/2016
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6:30 PM
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FDA MedWatch RSS Feed
|
Bacteria and/or particulate matter present in an unsterile solution could pass through to a compounded prepared solution, which could lead to adverse health consequences.
Full Article
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Homeopathic Teething Tablets and Gels: FDA Warning - Risk to Infants and Children
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9/30/2016
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6:00 PM
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FDA MedWatch RSS Feed
|
Adverse events reported to the agency, including seizures in infants and children who were given these products.
Full Article
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Small Battery Drive and Small Battery Drive II Adaptor and Light Adaptor by DePuy Synthes: Class I Recall - Possible Explosion Risk
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9/28/2016
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6:40 PM
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FDA MedWatch RSS Feed
|
Potential for the adaptors to produce extreme internal pressure, which may cause the device to explode. The use of affected products may cause serious adverse health consequences, including death.
Full Article
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Wells Pharmacy Network Issues Voluntary Nationwide Recall of Sterile Products due to Concern for Lack of Sterility Assurance
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9/22/2016
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6:54 PM
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FDA Pet Health RSS Feed
|
Ocala, Florida - Wells Pharmacy Network ("WPN") is voluntarily recalling all sterile human and veterinary products prepared between February 22, 2016 and September 14, 2016, and that remain within expiry due to the Food and Drug Administration's ("FDA") concern over a lack of sterility assurance.
Full Article
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Sterile Products by Wells Pharmacy Network: Recall - Concern for Lack of Sterility Assurance
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9/22/2016
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6:50 PM
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FDA MedWatch RSS Feed
|
Administration of a drug product intended to be sterile that has microbial contamination may result in infections that may be serious and life-threatening.
Full Article
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Hyoscyamine Sulfate 0.125mg by Virtus Pharmaceuticals: Recall - Superpotent and Subpotent Test Results
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9/15/2016
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3:20 PM
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FDA MedWatch RSS Feed
|
Adverse event reports involving hallucinations, stroke-like symptoms, confusion, dizziness, blurred vision, dry mouth, slurred speech, imbalance, and disorientation.
Full Article
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GlucaGen HypoKit (glucagon [rDNA origin] for injection) by Novo Nordisk Inc: Recall - Detached Needles on Syringe
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9/9/2016
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6:07 PM
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FDA MedWatch RSS Feed
|
Affected product with detached needle cannot be used as prescribed. Untreated hypoglycemia can eventually lead to unconsciousness and seizures, which can prove fatal.
Full Article
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Family Care Eye Wash by United Exchange Corp: Recall - Microbial Contamination
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9/8/2016
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12:20 PM
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FDA MedWatch RSS Feed
|
Use of a contaminated product could be calamitous for any population since there is a reasonable probability of a potentially sight-threatening eye infection.
Full Article
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Eye Wash/Eye Irrigating Solutions Distributed by Major Pharmaceuticals and Rugby Laboratories: Recall - Microbial Contamination
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9/7/2016
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9:17 PM
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FDA MedWatch RSS Feed
|
Use of a contaminated product could be calamitous for any population since there is a reasonable probability of a potentially sight-threatening eye infection.
Full Article
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Ovarian Cancer Screening Tests: Safety Communication - FDA Recommends Against Use
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9/7/2016
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6:40 PM
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FDA MedWatch RSS Feed
|
Using unproven ovarian cancer screening tests may be harmful for women with increased risk for developing ovarian cancer.
Full Article
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Kinetic Technologies and Kinetic Vet Announce the Voluntary Nationwide Recall of Hy-Optic, OptiVet and Optimend Due to Deficiencies in Sterility
|
9/2/2016
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9:00 PM
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FDA Pet Health RSS Feed
|
Kinetic Technologies and Kinetic Vet located in Lexington, KY has voluntarily recalled Hy-Optic ? lot # 10092015, OptiVet ? lot # 12032015 and Optimend ? lot # 01122015. This voluntary recall is the result of deficiencies in sterility, which may lead to deteriorating eye conditions, irritation and/or infection.
Full Article
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Mass Spectrometers by Sciex: Safety Communication - Incorrect Assignment of Test Results
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9/1/2016
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4:40 PM
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FDA MedWatch RSS Feed
|
Health care professionals may make inaccurate clinical diagnoses or inaccurate medical treatment decisions for patients by relying on incorrect results from the devices, which may lead to serious adverse health consequences.
Full Article
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Vascu-Guard Peripheral Vascular Patch by Baxter International: Letter to Health Care Providers - Potential Risk of Severe Bleeding and Hematomas
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9/1/2016
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1:00 PM
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FDA MedWatch RSS Feed
|
Reports of intraoperative or postoperative bleeding and hematomas, some of which required additional intervention, and three patient deaths potentially related to this issue that occurred shortly after carotid endarterectomy surgery.
Full Article
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Opioid Pain or Cough Medicines Combined With Benzodiazepines: Drug Safety Communication - FDA Requiring Boxed Warning About Serious Risks and Death
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8/31/2016
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4:01 PM
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FDA MedWatch RSS Feed
|
Combined use of opioid medicines with benzodiazepines or other drugs that depress the central nervous system has resulted in serious side effects, including slowed or difficult breathing and deaths.
Full Article
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Dietary Supplements by Ton Shen Health/Life Rising: Recall - Elevated Lead Levels
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8/30/2016
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8:30 PM
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FDA MedWatch RSS Feed
|
UPDATED 08/30/2016. Company press release with additional information added. Recall expanded to include all lots of DHZC-2 tablets.
Full Article
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Lamotrigine Orally Disintegrating Tablet 200 mg by Impax: Recall - Incorrect Labeling of Blister Cards
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8/29/2016
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7:17 PM
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FDA MedWatch RSS Feed
|
Patients could take less than their intended lamotrigine dose, which may lead to reduced therapeutic effects of lamotrigine and reemergence of epilepsy or bipolar disorder symptoms.
Full Article
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Programmable Syringe Pumps: FDA Safety Communication - Problems With Fluid Flow Continuity at Low Infusion Rates
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8/25/2016
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4:00 PM
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FDA MedWatch RSS Feed
|
Reports of serious clinical consequences, such as over- and under- infusion of high risk or life-sustaining medications, occlusion detection failures, inadvertent boluses caused by inconsistent fluid delivery, and other malfunctions.
Full Article
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Eyesaline Eyewash by Honeywell: Recall - Microbial Contamination
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8/22/2016
|
|
3:45 PM
|
FDA MedWatch RSS Feed
|
Klebsiella pneumoniae contamination, if present in the product, may result in infections that may be sight-threatening.
Full Article
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Oxacillin for Injection, USP, 10g by Sagent: Recall - Iron Oxide Particulate Matter
|
8/19/2016
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|
5:00 PM
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FDA MedWatch RSS Feed
|
Administered of metal particulate may result in serious adverse events such as stroke, heart attack, respiratory failure, kidney failure, or liver failure.
Full Article
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Cetylev (acetylcysteine) Effervescent Tablets for Oral Solution by Arbor Pharmaceuticals: Recall - Inadequate Seal of Blister Pack
|
8/18/2016
|
|
6:20 PM
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FDA MedWatch RSS Feed
|
Risk of sub-therapeutic dose as well as potential microbial contamination.
Full Article
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Comfort Shield Barrier Cream Cloths by Sage Products: Recall - Product Contamination
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8/17/2016
|
|
6:15 PM
|
FDA MedWatch RSS Feed
|
UPDATED 8/16/2016. Recall expanded to include an additional lot. Product with B. cepacia may cause serious, life-threatening infections in patients whose bodies cannot fight disease or in hospitalized patients, as well as certain other patient groups.
Full Article
|
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System 83 Plus Automated Endoscope Reprocessors by Custom Ultrasonics: FDA Safety Communication - FDA Recommends Stop Using for Reprocessing Duodenoscopes
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8/17/2016
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1:30 PM
|
FDA MedWatch RSS Feed
|
Health care facilities should have transitioned to alternative methods of reprocessing of duodenoscopes. System 83 Plus AERs remain in service for the reprocessing endoscopes other than duodenoscopes.
Full Article
|
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NucliSENS easyMAG Magnetic Silica for Nucleic Acid Extraction by BioMerieux: Recall - Potential Inaccurate Test Results
|
8/12/2016
|
|
11:20 PM
|
FDA MedWatch RSS Feed
|
The detection problem could lead to a risk of false negative or invalid results for clinical laboratory tests. The use of the affected product may cause serious adverse health consequences, including death.
Full Article
|
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DHZC-2 Tablet by Ton Shen Health: Recall - Possible Health Risk
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8/12/2016
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|
6:00 PM
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FDA MedWatch RSS Feed
|
Tablets have the potential to be contaminated with elevated levels of lead, a naturally occurring element which can affect multiple body system and particularly harmful to young children.
Full Article
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Liquid Drug and Dietary Supplement Products by PharmaTech: Recall - Risk of Product Contamination
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8/9/2016
|
|
12:00 PM
|
FDA MedWatch RSS Feed
|
Use of B. cepacia contaminated product could result in serious or life-threatening infections in patients with compromised immune systems and in patients with chronic lung conditions such as cystic fibrosis.
Full Article
|
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AVEA Ventilator by CareFusion: Class I Recall - Electrical Issue May Cause Unexpected Shutdown
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7/28/2016
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6:20 PM
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FDA MedWatch RSS Feed
|
Ventilator shutdown may cause serious adverse health consequences, including death.
Full Article
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Fluoroquinolone Antibacterial Drugs for Systemic Use: Drug Safety Communication - Warnings Updated Due to Disabling Side Effects
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7/26/2016
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|
4:01 PM
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FDA MedWatch RSS Feed
|
Use associated with disabling and potentially permanent side effects of the tendons, muscles, joints, nerves, and central nervous system that can occur together in the same patient.
Full Article
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HCG and Sermorelin by Talon Compounding Pharmacy: Recall - Lack of Sterility Assurance
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7/22/2016
|
|
6:15 PM
|
FDA MedWatch RSS Feed
|
Administration of a drug product intended to be sterile that is compromised can result in health hazards including risk of serious infection or other complications.
Full Article
|
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Angiodynamics Soft Vu Omni Flush Angiographic Catheter by Stryker Sustainability Solutions (formerly Ascent Healthcare Solutions): Class I Recall - Tip Separation
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7/22/2016
|
|
2:00 PM
|
FDA MedWatch RSS Feed
|
Risk of surgical intervention to retrieve a separated segment, or other serious adverse health consequences such as internal organ injury, stroke, kidney failure, intestinal failure, and death.
Full Article
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WEN by Chaz Dean Cleansing Conditioners: FDA Statement - Investigation of Adverse Event Reports
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7/19/2016
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5:00 PM
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FDA MedWatch RSS Feed
|
Reports of hair loss, hair breakage, balding, itching, and rash.
Full Article
|
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Oral Liquid Docusate Sodium by PharmaTech : Recall - Contaminated with B. Cepacia
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7/16/2016
|
|
4:00 AM
|
FDA MedWatch RSS Feed
|
The agency confirmed the product has been contaminated with Burkholderia Cepacia, a bacteria linked to an outbreak in five states.
Full Article
|
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INRatio and INRatio2 PT/INR Monitor System by Alere: Recall - Potentially Inaccurate INR Results
|
7/12/2016
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|
7:30 PM
|
FDA MedWatch RSS Feed
|
Alere is working with the FDA to determine the most appropriate timing for product discontinuation and will provide guidance on transitioning patients to an alternate solution.
Full Article
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Dream Body 450mg, Dream Body Extreme Gold 800mg, Dream Body Advanced 400mg: Recall - Undeclared Drug Ingredient
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7/5/2016
|
|
4:30 PM
|
FDA MedWatch RSS Feed
|
Sibutramine may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.
Full Article
|
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HeartWare Ventricular Assist Device (HVAD) Batteries by HeartWare Inc.: Class I Recall - Premature Power Depletion
|
6/29/2016
|
|
4:20 PM
|
FDA MedWatch RSS Feed
|
Batteries may lose power prematurely due to faulty cells.
Full Article
|
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Purina Animal Nutrition Initiates Recall of Purina Medicated Sheep Feed due to Elevated Copper Level
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6/27/2016
|
|
3:02 PM
|
FDA Pet Health RSS Feed
|
Purina Animal Nutrition LLC of Arden Hills, Minnesota, is voluntarily recalling one lot of Purina Lamb Grower B30 Medicated Sheep Feed packaged in the green and white generic paper LAND O LAKES Feed bags.
Full Article
|
|
Radagast Pet Food, Inc. Is Voluntarily Recalling Four Lots Of Frozen Rad Cat Raw Diet® Due To Possibly Salmonella And Listeria Monocytogenes Health Risk
|
6/24/2016
|
|
12:50 AM
|
FDA Pet Health RSS Feed
|
Radagast Pet Food, Inc. (Portland, OR) has announced a voluntary recall of four lots of frozen Rad Cat Raw Diet products, sold in 8oz., 16oz., and 24oz. tubs, and free 1oz sample cups, due to the potential to be contaminated with Salmonella and/or Listeria monocytogenes. Salmonella and Listeria monocytogenes can affect animals eating the products and there is risk to humans from handling contaminated pet products, especially if they have not thoroughly washed their hands after having contact with the products or any surfaces exposed to these products.
Full Article
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Canagliflozin (Invokana, Invokamet) and Dapagliflozin (Farxiga, Xigduo XR): Drug Safety Communication - Strengthened Kidney Warnings
|
6/14/2016
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|
2:00 PM
|
FDA MedWatch RSS Feed
|
Revised warnings in the drug labels to include information about acute kidney injury and added recommendations to minimize this risk.
Full Article
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Nature Made (Various Products) by Pharmavite LLC: Recall - Possible Health Risk
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6/8/2016
|
|
6:20 PM
|
FDA MedWatch RSS Feed
|
Salmonella can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.
Full Article
|
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Step 2 60 Gold by The Body Shot Bar: Recall - Undeclared Drug Ingredients
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6/7/2016
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|
6:55 PM
|
FDA MedWatch RSS Feed
|
Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.
Full Article
|
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Loperamide (Imodium): Drug Safety Communication - Serious Heart Problems With High Doses From Abuse and Misuse
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6/7/2016
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|
1:00 PM
|
FDA MedWatch RSS Feed
|
Majority of reported problems occurred in individuals intentionally misusing and abusing high doses of loperamide in attempts to self-treat opioid withdrawal symptoms or to achieve a feeling of euphoria.
Full Article
|
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Over-the-Counter Antacid Products Containing Aspirin: FDA Drug Safety Communication - Serious Bleeding Risk
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6/6/2016
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|
4:00 AM
|
FDA MedWatch RSS Feed
|
Risk of serious bleeding when using nonprescription, also known as over-the-counter or OTC, aspirin-containing antacid products.
Full Article
|
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St?ckert 3T Heater-Cooler System by Sorin Group Deustchland GmbH: Safety Communication - Reports of Mycobacterium Chimaera Infections
|
6/1/2016
|
|
5:55 PM
|
FDA MedWatch RSS Feed
|
There may be a higher risk of patient infection associated with surgeries that introduced a prosthetic product/material [e.g., heart valve, graft, LVAD], or heart transplants when the 3T was used.
Full Article
|
|
Capnostream 20 and Capnostream 20p Patient Monitor Battery Packs by Medtronic Respiratory and Monitoring Solutions: Class I Recall - Potential Fire Risk
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5/27/2016
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|
2:55 PM
|
FDA MedWatch RSS Feed
|
Manufacturing defect causes an increase in temperature within battery that may cause a fire.
Full Article
|
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Hummi Micro-Draw Blood Transfer Device by Hummingbird Med Devices: Class I Recall - Potential for Parts to Disconnect
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5/26/2016
|
|
5:10 PM
|
FDA MedWatch RSS Feed
|
Y-shaped connector and the yellow tube may disconnect from each other prior to or during use. This could lead to blood or fluid leakage, which may result in serious adverse health consequences, including death.
Full Article
|
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Nizoral (ketoconazole) Oral Tablets: Drug Safety Communication - Prescribing for Unapproved Uses including Skin and Nail Infections Continues; Linked to Patient Death
|
5/19/2016
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|
4:00 AM
|
FDA MedWatch RSS Feed
|
Skin and nail fungal infections in otherwise healthy persons are not life-threatening, and so the risks associated with oral ketoconazole outweigh the benefits. Posted 05/19/2016
Full Article
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Well Care Compounding Pharmacy Sterile Compounded Products: Recall - Lack Of Sterility Assurance
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5/18/2016
|
|
5:00 PM
|
FDA MedWatch RSS Feed
|
Administration of a drug product intended to be sterile that is compromised may result in serious and potentially life-threatening infections or death.
Full Article
|
|
Canagliflozin (Invokana, Invokamet): Drug Safety Communication - Clinical Trial Results Find Increased Risk of Leg and Foot Amputations
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5/18/2016
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|
4:56 PM
|
FDA MedWatch RSS Feed
|
FDA is currently investigating this new safety issue. Patients should not stop or change their diabetes medicines.
Full Article
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Well Care Compounding Pharmacy Issues Voluntary Statewide Recall of All Sterile Compounded Products Due to Lack Of Assurance if Sterility Concerns
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5/17/2016
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|
11:45 PM
|
FDA Pet Health RSS Feed
|
Well Care Compounding Pharmacy, Las Vegas, Nevada is performing a voluntary statewide recall in Nevada on all unexpired sterile compounded products due to the Food and Drug Administration's (FDA) concern over lack of sterility assurance. The recall impacts all sterile compounded products distributed between 01/01/2016-04/29/2016.
Full Article
|
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SOS Telecom Products: Recall - Undeclared Drug Ingredient
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5/13/2016
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2:50 PM
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FDA MedWatch RSS Feed
|
Sildenafil may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels.
Full Article
|
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BiCNU (carmustine for injection): FDA Alert - Counterfeit Product Discovered in Some Foreign Countries
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5/13/2016
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|
2:40 PM
|
FDA MedWatch RSS Feed
|
FDA urges health care professionals to purchase drug products only from legitimate suppliers.
Full Article
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|
Fluoroquinolone Antibacterial Drugs: Drug Safety Communication - FDA Advises Restricting Use for Certain Uncomplicated Infections
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5/12/2016
|
|
5:35 PM
|
FDA MedWatch RSS Feed
|
Serious side effects associated with fluoroquinolones generally outweigh the benefits for patients with sinusitis, bronchitis, and uncomplicated urinary tract infections who have other treatment options.
Full Article
|
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Olanzapine: Drug Safety Communication - FDA Warns About Rare But Serious Skin Reactions
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5/10/2016
|
|
4:01 PM
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FDA MedWatch RSS Feed
|
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) can result in injury to organs including the liver, kidneys, lungs, heart, or pancreas, and can lead to death.
Full Article
|
|
Manna Pro Products Issues Limited Voluntary Recall of Chick Starter Medicated Distributed in California, Nevada, Oregon, and Hawaii
|
5/10/2016
|
|
3:30 PM
|
FDA Pet Health RSS Feed
|
Manna Pro Products, LLC is voluntarily recalling a single lot (MADE 11/23/15 WP-2) of Manna Pro Chick Starter Medicated, UPC 0 95668 10555 6, packaged in 25 pound bags because it may contain excessive salt. Symptoms of excessive salt intake include increased water consumption, anorexia, and weight loss, and may lead to death.
Full Article
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Dialog+ Hemodialysis Systems by B. Braun Medical: Class I Recall - Defective Conductivity Sensors
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5/4/2016
|
|
2:30 PM
|
FDA MedWatch RSS Feed
|
The presence of air in dialysis fluid may lead to improper blood filtration, causing serious adverse health consequences, including death.
Full Article
|
|
Beacon Tip Technology Catheters by Cook Medical: Recall - Polymer Degradation of the Catheter Tip
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5/4/2016
|
|
1:10 PM
|
FDA MedWatch RSS Feed
|
Degradation could lead to loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment.
Full Article
|
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Aripiprazole (Abilify, Abilify Maintena, Aristada): Drug Safety Communication - FDA Warns About New Impulse-control Problems
|
5/3/2016
|
|
4:30 PM
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FDA MedWatch RSS Feed
|
Compulsive or uncontrollable urges to gamble, binge eat, shop, and have sex have been reported with the use of
aripiprazole, and may result in harm to the patient and others if not recognized.
Full Article
|
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Brintellix (vortioxetine): Drug Safety Communication - Brand Name Change to Trintellix, to Avoid Confusion With Antiplatelet Drug Brilinta (ticagrelor)
|
5/2/2016
|
|
7:10 PM
|
FDA MedWatch RSS Feed
|
During transition from the name Brintellix to Trintellix, prescribers can reduce the risk of name confusion by including the generic name of the medication they are ordering, in addition to the brand name and indication for use.
Full Article
|
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Making It A Lifestyle, L.L.C. Supplements 3rd Degree, Black Gold X Advanced, and Black Label X: Recall - Undeclared Drug Ingredients
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5/2/2016
|
|
2:25 PM
|
FDA MedWatch RSS Feed
|
Undeclared sibutramine or sildenafil poses a threat to consumers.
Full Article
|
|
Sensorcaine-MPF (bupivacaine HCl) by Fresenius Kabi: Recall - Presence of Particulate Matter
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4/26/2016
|
|
9:30 PM
|
FDA MedWatch RSS Feed
|
Administration of a solution containing glass particulate matter may result in inflammation and injury, or cause blockage of vasculature around the eye or emboli in the vasculature of eye nerves.
Full Article
|
|
Fluconazole (Diflucan): Drug Safety Communication - FDA Evaluating Study Examining Use of Oral Fluconazole (Diflucan) in Pregnancy
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4/26/2016
|
|
1:00 PM
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FDA MedWatch RSS Feed
|
Danish study shows possible increased risk of miscarriage. FDA advises cautious prescribing of oral fluconazole in pregnancy, until more is understood about this study.
Full Article
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Covidien Oridion Labeled Capnostream 20 and Capnostream 20p Patient Monitor Battery Packs by Medtronic: Recall - Risk of Thermal Damage
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4/20/2016
|
|
8:30 PM
|
FDA MedWatch RSS Feed
|
Thermal damage may cause fire, resulting in smoke inhalation and minor burns.
Full Article
|
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March 2016 - Drug Safety Labeling Changes
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4/15/2016
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|
12:22 PM
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FDA MedWatch RSS Feed
|
Drug Safety Labeling Changes includes 35 products with revisions to Prescribing Information. Posted 04/15/2015
Full Article
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50 Percent Magnesium Sulfate Injection, USP by Hospira: Recall - Presence Of Particulate Matter
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4/14/2016
|
|
3:00 PM
|
FDA MedWatch RSS Feed
|
Administration may result in localized swelling, redness, pain at the site of administration or veins, allergic reactions to the foreign particle, microembolic effects as well as possible fetal harm.
Full Article
|
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Focus Diagnostics Laboratory Examination Kits: Class I Recall - Inaccurate Test Results
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4/14/2016
|
|
11:30 AM
|
FDA MedWatch RSS Feed
|
Inaccurate results may lead to improper patient treatment for HSV or GAS and may cause serious adverse health consequences, including death.
Full Article
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Super Herbs Capsules: Recall - Undeclared Drug Ingredients
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4/12/2016
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3:10 PM
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FDA MedWatch RSS Feed
|
Product poses significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.
Full Article
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Guardian II Hemostasis Valves by Vascular Solutions, Inc: Recall - Risk of Air Leakage
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4/11/2016
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6:40 PM
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FDA MedWatch RSS Feed
|
Air leakage may lead to an air embolism, which could result in serious injury or death.
Full Article
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Fetch 2 Aspiration Catheter by Boston Scientific: Recall - Shaft Breakage
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4/11/2016
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4:00 AM
|
FDA MedWatch RSS Feed
|
Embolism of device fragments could lead to obstruction of blood flow or additional intervention to remove a device fragment surgically.
Full Article
|
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G4 Platinum and G5 Mobile Continuous Glucose Monitoring System Receivers by Dexcom: Class I Recall - Audible Alarm Failure
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4/11/2016
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4:00 AM
|
FDA MedWatch RSS Feed
|
Relying on this product for notification of low/high blood sugar could result in serious adverse consequences, including death as the auditory alarm may not sound and users might not be notified of low/high blood sugar.
Full Article
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Metformin-containing Drugs: Drug Safety Communication - Revised Warnings for Certain Patients With Reduced Kidney Function
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4/8/2016
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5:00 PM
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FDA MedWatch RSS Feed
|
FDA requiring changes to metformin labeling to provide specific recommendations on use in patients with mild to moderate kidney impairment.
Full Article
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Diabetes Medications Containing Saxagliptin and Alogliptin: Drug Safety Communication - Risk of Heart Failure
|
4/5/2016
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|
6:10 PM
|
FDA MedWatch RSS Feed
|
FDA adding new Warnings and Precautions to the labels of medicines that contain saxagliptin or alogliptin to inform of the potential increased risk of heart failure.
Full Article
|
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Continuum Labs LGD-4033 by Invisiblu International: Recall - Investigational Drug Not Approved for Use
|
4/5/2016
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4:30 PM
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FDA MedWatch RSS Feed
|
Product found to contain LGD-4033 Ligandrol, an investigational drug not approved for use. The risks of using this product are unknown.
Full Article
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Urogynecologic Surgical Mesh Implants by Boston Scientific: Notification ? Potential for Counterfeit Raw Material
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4/1/2016
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6:45 PM
|
FDA MedWatch RSS Feed
|
FDA not recommending removal of this device, since the available data do not suggest any decreased benefit.
Full Article
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Interference between Computed Tomography (CT) and Electronic Medical Devices: Notification ? Current Understanding of Potential Risk
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4/1/2016
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4:15 PM
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FDA MedWatch RSS Feed
|
Information about a rare and preventable type of interference between CT and electronic medical devices.
Full Article
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Sterile Drug Products by Medaus Pharmacy: FDA Alert - Lack of Sterility Assurance
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4/1/2016
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|
4:00 AM
|
FDA MedWatch RSS Feed
|
Administration of a non-sterile product, intended to be sterile, may result in serious and potentially life-threatening infections or death.
Full Article
|
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5 Percent Dextrose Injection USP in PAB Container by B. Braun Medical: Recall - Leakage and/or Particulate Matter
|
3/29/2016
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|
7:40 PM
|
FDA MedWatch RSS Feed
|
Intravenous administration of a non-sterile product can result in serious infections that may be life-threatening.
Full Article
|
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OxySure Portable Emergency Oxygen System, Model 615 by OxySure Therapeutics, Inc: FDA Safety Communication - Do Not Use
|
3/29/2016
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|
5:00 PM
|
FDA MedWatch RSS Feed
|
Patients and other users of the affected device are at risk for serious adverse health consequences, such as burns and death.
Full Article
|
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Revised Press Release For: "Reliable Drug" Recall of all Compounded Medications Due to a Potential for Mislabeling and Lack of Quality Assurance
|
3/29/2016
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|
1:42 AM
|
FDA Pet Health RSS Feed
|
Reliable Drug Pharmacy is voluntarily recalling all unexpired lots of compounded products due to concern of lack of quality assurance and potential mislabeling. All unexpired lots are subject to the recall.
Full Article
|
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Compounded Products by Reliable Drug Pharmacy: Recall - Potential for Mislabeling and Lack of Quality Assurance
|
3/28/2016
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|
2:00 PM
|
FDA MedWatch RSS Feed
|
Stop using recalled product immediately and arrange for the return of unused product.
Full Article
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"Reliable Drug" Recalls All Compounded Medications Due to a Potential for Mislabeling and Lack of Quality Assurance
|
3/27/2016
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|
1:08 PM
|
FDA Pet Health RSS Feed
|
Reliable Drug Pharmacy is voluntarily recalling all unexpired lots of compounded products due to concern of lack of quality assurance and potential mislabeling. All unexpired lots are subject to the recall. All recalled products were distributed to patients and veterinarians within California.
Full Article
|
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Smallbatch Pets Inc. Voluntarily Recalls Frozen Dog Duckbatch Sliders Due to Possible Salmonella and Listeria Monocytogenes Health Risk
|
3/26/2016
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|
10:19 PM
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FDA Pet Health RSS Feed
|
Smallbatch Pets Inc. is voluntarily recalling one lot of frozen dog duckbatch sliders due to their potential to be contaminated with Salmonella and Listeria monocytogenes.
Full Article
|
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Best Bentonite Clay by Best Bentonite: FDA Alert - Risk of Lead Poisoning
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3/23/2016
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|
9:00 PM
|
FDA MedWatch RSS Feed
|
Exposure to lead can cause serious damage to the central nervous system, kidneys, and immune system.
Full Article
|
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NOW Health Group Dietary Supplements: Recall - Mislabeling
|
3/22/2016
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|
7:40 PM
|
FDA MedWatch RSS Feed
|
People with an allergy or severe sensitivity to soy risk serious or life-threatening allergic reaction if they consume these products.
Full Article
|
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Opioid Pain Medicines: Drug Safety Communication - New Safety Warnings Added to Prescription Opioid Medications
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3/22/2016
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|
4:15 PM
|
FDA MedWatch RSS Feed
|
FDA is warning about several safety issues with the class of opioid pain medicines, including serotonin syndrome, adrenal insufficiency, and androgen deficiency.
Full Article
|
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Sodium Bicarbonate Injection, USP by Hospira: Recall - Particulate Matter
|
3/21/2016
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|
3:10 PM
|
FDA MedWatch RSS Feed
|
Administration of product with particulates may result in localized inflammation, allergic reaction including anaphylaxis, granuloma formation, microembolic effects, or delay of therapy.
Full Article
|
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MFA Incorporated issues recall on rabbit feed pellets (both bagged and bulk) in southwest Missouri due to excessive sodium
|
3/20/2016
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|
1:09 AM
|
FDA Pet Health RSS Feed
|
MFA Incorporated today announced the recall of bagged and bulk MFA 16% and 17% rabbit feed. The product was distributed to MFA retail stores in southwest Missouri.
Full Article
|
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GlideScope Titanium Single-Use Video Laryngoscope by Verathon: Class I Recall - Potential Video Feed Disruption
|
3/18/2016
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|
3:00 PM
|
FDA MedWatch RSS Feed
|
Disrupted or unstable video image may lead to delayed tracheal tube insertion, intubation failure, and other serious adverse health consequences, including hypoxemia, end organ damage, or death.
Full Article
|
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Eye Drops: FDA Statement - Potential Risk of Loose Safety Seals
|
3/15/2016
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|
11:55 PM
|
FDA MedWatch RSS Feed
|
A loose safety seal or ring presents a safety risk as it may cause eye injuries.
Full Article
|
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Duodenoscope Models TJF-160F and TJF-160VF by Olympus: Safety Communication - Reprocessing Instructions Validated
|
3/15/2016
|
|
5:25 PM
|
FDA MedWatch RSS Feed
|
FDA reviewed updated reprocessing instructions and validation data; FDA recommends that facilities implement them as soon as possible.
Full Article
|
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Arrow International Intra-Aortic Balloon Catheter Kits and Percutaneous Insertion Kits by Teleflex Incorporated : Class I Recall - Sheath Body may become Separated from Sheath Hub
|
3/11/2016
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|
5:00 AM
|
FDA MedWatch RSS Feed
|
If the separation occurs, patient may bleed from the sheath. If bleeding is not promptly addressed, significant blood loss/exsanguination, interruption/loss of intra-aortic balloon pump treatment may occur.
Full Article
|
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Amikacin Sulfate Injection USP, 1 gram/4mL (250 mg/mL) Vials by Teva: Recall - Glass Particulate Matter
|
3/10/2016
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|
6:45 PM
|
FDA MedWatch RSS Feed
|
Administration of a glass particulate may result in local irritation, swelling, and blockage or clotting in blood vessels, which may be life-threatening if a critical organ is affected.
Full Article
|
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Human and Animal Sterile Drug Products by I.V. Specialty: FDA Alert - Lack of Sterility Assurance
|
3/9/2016
|
|
11:30 PM
|
FDA MedWatch RSS Feed
|
Administration of a non-sterile product intended to be sterile may result in serious and potentially life threatening infections or death.
Full Article
|
|
MitraClip Delivery System by Abbott: Safety Notice - Reinforcement of Proper Procedures to Operate and Deploy
|
2/29/2016
|
|
3:30 PM
|
FDA MedWatch RSS Feed
|
Abbott requiring training of all MitraClip implanting physicians to ensure continued safe use of the device.
Full Article
|
|
Neurosurgical Head Holders (Skull Clamps) : FDA Safety Communication - Device Slippage
|
2/25/2016
|
|
5:00 AM
|
FDA MedWatch RSS Feed
|
Unintended patient movement during surgical procedures may result in injuries including skull fractures, facial injuries (bruises and cuts), deep cuts (lacerations), and blood clots (hematoma). Posted 02/25/2016
Full Article
|
|
ED-3490TK Video Duodenoscope by Pentax: FDA Safety Communication - Pentax Validates Reprocessing Instructions
|
2/19/2016
|
|
5:00 PM
|
FDA MedWatch RSS Feed
|
FDA reviewed updated reprocessing instructions and validation data; FDA recommends that facilities
implement them as soon as possible.
Full Article
|
|
0.9 Percent Sodium Chloride Solution for Irrigation by Baxter: Recall - Presence of Particulate Matter
|
2/18/2016
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|
6:38 PM
|
FDA MedWatch RSS Feed
|
Use of Sodium Chloride Irrigation solution with foreign material contamination could result in inflammatory reaction, foreign body reaction, and infection which could be life-threatening.
Full Article
|
|
Morphine Sulfate 0.5 mg/mL Preservative Free in 0.9 percent Sodium Chloride by by Pharmakon Pharmaceuticals: Recall - Super-potent Product
|
2/17/2016
|
|
1:15 PM
|
FDA MedWatch RSS Feed
|
Injecting a patient with super-potent morphine could result in serious consequences including respiratory depression, coma, and death.
Full Article
|
|
Central Venous Catheters and Pressure Monitoring Sets and Trays by Cook Medical: Recall - Catheter Tip Fracture and/or Separation
|
2/11/2016
|
|
12:45 PM
|
FDA MedWatch RSS Feed
|
Risk of stroke, kidney injury, or damage to the intestines or limbs.
Full Article
|
|
Syrspend SF and Syrspend SF Grape Suspending Agents by Fagron: FDA Alert - Microbial Contamination with Yeast
|
2/11/2016
|
|
12:30 AM
|
FDA MedWatch RSS Feed
|
If an immunocompromised patient or a child with an immature immune system ingests the contaminated product, there is a potential the patient will get an infection for which systemic antimicrobial therapy would be necessary.
Full Article
|
|
Oxylog 2000 Plus, 3000, and 3000 Plus Emergency Transport Ventilators by Dr?ger Medical: Class I Recall - System Error May Lead to a Halt in Ventilation Therapy
|
2/10/2016
|
|
6:00 PM
|
FDA MedWatch RSS Feed
|
If the device operator does not intervene, the patient may not receive enough oxygen and could suffer serious adverse health consequences, including injury or death.
Full Article
|
|
Pink Bikini and Shorts on The Beach Dietary Supplements by Lucy's Weight Loss System: Recall - Undeclared Drug Ingredient
|
1/29/2016
|
|
5:00 AM
|
FDA MedWatch RSS Feed
|
May contain sibutramine, phenolphthalein, and/or diclofenac.
Full Article
|
|
Bentonite Me Baby ? Bentonite Clay by Alikay Naturals: Consumer Warning - Risk of Lead Poisoning
|
1/28/2016
|
|
11:50 PM
|
FDA MedWatch RSS Feed
|
Exposure to lead can cause serious damage to the central nervous system, the kidneys, and the immune system.
Full Article
|
|
SPOTCHEM II Test Strips by Arkray: Class I Recall - Inaccurate Blood Sugar Readings
|
1/28/2016
|
|
7:50 PM
|
FDA MedWatch RSS Feed
|
Because the test strips are reporting falsely low blood glucose, there is a risk that the health care provider would not diagnose hyperglycemia (high blood sugar) in a timely manner and fail to treat elevated blood glucose levels.
Full Article
|
|
Crema Piel De Seda (Silky Skin Cream) by Viansilk: Consumer Warning - Risk of Mercury Poisoning
|
1/28/2016
|
|
5:00 AM
|
FDA MedWatch RSS Feed
|
Exposure to mercury can cause serious health problems, such as kidney and nervous system damage.
Full Article
|
|
Moves Ventilator System by Thornhill Research: Class I Recall - Battery Problem
|
1/27/2016
|
|
9:30 PM
|
FDA MedWatch RSS Feed
|
The issue may prevent the ventilator from providing patient breathing support and could cause patient injury or death.
Full Article
|
|
Baxter IV Solutions (Select Lots): Recall - Potential for Leaking Containers and Particulate Matter
|
1/27/2016
|
|
12:30 PM
|
FDA MedWatch RSS Feed
|
Solution contamination could lead to a worsened patient condition or death.
Full Article
|
|
Optisure Dual Coil Defibrillation Leads by St. Jude Medical: Class I Recall - Damage May Prevent Patient Therapy
|
1/26/2016
|
|
7:50 PM
|
FDA MedWatch RSS Feed
|
Manufacturing error may have caused damage to the insulation layer of one of the shock coils. This could result in the inability of the defibrillator to deliver electrical therapy to the patient.
Full Article
|
|
Carnivore Meat Company, LLC Voluntarily Issues a Recall for One Lot of Frozen Pet Food
|
1/22/2016
|
|
7:07 PM
|
FDA Pet Health RSS Feed
|
Carnivore Meat Company is recalling a single lot of Vital Essentials Frozen Chicken Patties Entree for Dogs, due to concerns of the possible presence of Salmonella. Healthy people infected with Salmonella should monitor themselves for some or all of the following symptoms: nausea, vomiting, diarrhea or bloody diarrhea, abdominal cramping and fever.
Full Article
|
|
Abbott's Compounding Pharmacy Issues Voluntary Recall of All Lots of Unexpired Sterile Human and Animal Compounded Products Due to Lack of Sterility Assurance
|
1/16/2016
|
|
10:56 PM
|
FDA Pet Health RSS Feed
|
Abbott's Compounding Pharmacy is voluntarily recalling all unexpired lots of sterile compounded products due to concerns of lack of sterility assurance. All unexpired lots are subject to the recall.
Full Article
|
|
Licorice Coughing Liquid OTC Cough Syrup by Ma Ying Long Pharmaceutical Group: CDER Alert - Contains Unidentified Morphine
|
1/16/2016
|
|
5:00 AM
|
FDA MedWatch RSS Feed
|
Effects of morphine can include, but are not limited to, severe allergic reactions, respiratory depression, and death.
Full Article
|
|
Unexpired Sterile Human and Animal Compounded Products by Abbott's Compounding Pharmacy: Recall - Lack of Sterility Assurance
|
1/16/2016
|
|
5:00 AM
|
FDA MedWatch RSS Feed
|
Products include injectable medications, sterile solutions, eye drops, and eye ointments.
Full Article
|
|
Brainlab Cranial Image-Guided Surgery (IGS) System: Class I Recall - Navigation Inaccuracy
|
1/15/2016
|
|
6:20 PM
|
FDA MedWatch RSS Feed
|
Potential inaccuracies in the display by the navigation system could lead to inaccurate, ineffective medical procedures, and serious life-threatening injuries including death.
Full Article
|
|
Children's Guaifenesin Grape Liquid and Guaifenesin DM Cherry Liquid by Perrigo Company: Recall - Potential Defect with Dosage Cup
|
1/13/2016
|
|
2:00 PM
|
FDA MedWatch RSS Feed
|
An overdose of Guaifenesin DM may cause hyper excitability, rapid eye movements, changes in muscle reflexes, ataxia, dystonia, hallucinations, stupor, and coma.
Full Article
|
|
Pleural and Pneumopericardial Drainage Sets by Stryker Fuhrman - Class I Recall - Catheter May Break During Insertion
|
1/11/2016
|
|
5:00 AM
|
FDA MedWatch RSS Feed
|
May cause serious patient injury or death.
Full Article
|
|
Multiple Products by R Thomas Marketing: Recall - Undeclared Drug Ingredient
|
1/9/2016
|
|
7:45 PM
|
FDA MedWatch RSS Feed
|
Sildenafil may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels.
Full Article
|
|
L.G Compounded Asafoetida Powder by Shakti Group: Recall - Potential Contamination with Salmonella
|
1/8/2016
|
|
7:40 PM
|
FDA MedWatch RSS Feed
|
Salmonella can cause fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain.
Full Article
|
|
Evita V500 and Babylog VN500 Ventilators by Dr?ger: Class I Recall - Issue with Optional PS500 Battery Power Supply May Cause Ventilators to Shut Down Unexpectedly
|
1/6/2016
|
|
2:15 PM
|
FDA MedWatch RSS Feed
|
If the ventilator shuts down, a patient may not receive necessary oxygen, which could cause patient injury or death.
Full Article
|
|
Magnesium Sulfate in Water for Injection by Hospira: Recall - Incorrect Barcode Labeling on the Primary Container
|
1/6/2016
|
|
2:00 PM
|
FDA MedWatch RSS Feed
|
Potential for delay in treatment that can result in life-threatening seizures, stroke, cerebral hemorrhage and maternal death, and attendant risks to the fetus, including fetal demise.
Full Article
|
|
Surgical Convenience Packs and Trays by Customed, Inc.: FDA Safety Communication - Do Not Use
|
1/5/2016
|
|
3:30 PM
|
FDA MedWatch RSS Feed
|
The integrity, safety and efficacy cannot be assured because of inadequate testing. Use of these products pose a risk of serious adverse health consequences, such as infection and death.
Full Article
|
|
Baxter IV Solutions: Recall - Potential Presence of Particulate Matter
|
1/5/2016
|
|
2:45 PM
|
FDA MedWatch RSS Feed
|
Injecting a product containing particulate matter, in the absence of in-line filtration, may result in blockage of blood vessels, stroke, heart attack or damage to other organs such as the kidney or liver.
Full Article
|
|
Big Dog Natural Recalls Chicken and Fish Supreme Dog Food Due to Possible Salmonella and Listeria monocytogenes Health Risk
|
1/4/2016
|
|
8:50 PM
|
FDA Pet Health RSS Feed
|
Big Dog Natural of Brick, NJ is voluntary recalling a select production lot of Big Dog Natural raw dehydrated dog food Chicken Supreme potentially contaminated with Salmonella and Fish Supreme potentially contaminated with Listeria monocytogenes that was shipped in the week of 10/31/2015 to 11/13/2015 to online customers. Salmonella and Listeria monocytogenes can affect animals eating the products and there is risk to humans from handling contaminated pet products, especially if they have not thoroughly washed their hands after having contact with the products or any surfaces exposed to these products.
Full Article
|
|
Noxafil (posaconazole): Drug Safety Communication - Dosing Errors when Switching between Different Oral Formulations; Label Changes Approved
|
1/4/2016
|
|
5:00 AM
|
FDA MedWatch RSS Feed
|
Direct mg for mg substitution of the two formulations can result in drug levels that are lower/higher than needed to effectively treat certain fungal infections.
Full Article
|
|
4mg Norepinephrine Bitartrate (16mcg/mL) Added to 0.9% Sodium Chloride in 250mL Viaflex Bag and 8mg Norepinephrine Bitartrate (32mcg/mL) Added to 0.9% Sodium Chloride in 250mL Viaflex Bag by Pharmedium: Recall - Discoloration
|
12/31/2015
|
|
5:00 AM
|
FDA MedWatch RSS Feed
|
Discoloration is indicative of degradation and could result in decreased potency due to oxidation of norepinephrine bitartrate.
Full Article
|
|
Etest PIP/TAZO/CON-4 PTC 256 by bioM?rieux: Class I Recall ? Potential for Test Result Error
|
12/29/2015
|
|
5:20 PM
|
FDA MedWatch RSS Feed
|
Error may result in inappropriate treatment of a patient?s infection and could cause serious health consequences, including increased time in the hospital, unnecessary tests or procedures, treatment failure, sepsis, and even death.
Full Article
|
|
ED-530XT Duodenoscopes by FUJIFILM Medical Systems, U.S.A.: Safety Communication - FUJIFILM Medical Systems Validates Revised Reprocessing Instructions
|
12/23/2015
|
|
9:45 PM
|
FDA MedWatch RSS Feed
|
The FDA reviewed the revised reprocessing instructions and the validation data and determined they meet the Agency?s expectations.
Full Article
|
|
Perseus A500 Anesthesia Workstation by Draeger: Class I Recall - Faulty Power Switch May Cause Device to Stop Working
|
12/23/2015
|
|
9:00 PM
|
FDA MedWatch RSS Feed
|
If this occurs, ventilation may fail and the patient may not receive either anesthesia or enough oxygen.
Full Article
|
|
La' Trim Plus, Jenesis and Oasis by BeeXtreme: Recall - Undeclared Drug Ingredients
|
12/23/2015
|
|
6:00 PM
|
FDA MedWatch RSS Feed
|
Risk of increased blood pressure and/or pulse rate may present significant risk for patients with a history of CAD, CHF, arrhythmias or
stroke. Potentially serious GI disturbances, irregular heartbeat, and cancer with long-term use.
Full Article
|
|
Apexxx by Nuway Distributors: Recall - Undeclared Drug Ingredient
|
12/23/2015
|
|
5:00 AM
|
FDA MedWatch RSS Feed
|
Sildenafil may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels that may be life threatening.
Full Article
|
|
Various Products Distributed for Weight Loss by Bee Extremely Amazed: Recall - Undeclared Drug Ingredients
|
12/23/2015
|
|
5:00 AM
|
FDA MedWatch RSS Feed
|
Risk of increased blood pressure and/or pulse rate may present significant risk for patients with a history of CAD, CHF, arrhythmias or
stroke. Potentially serious GI disturbances, irregular heartbeat, and cancer with long-term use.
Full Article
|
|
Hand-held Laser Pointers: FDA Safety Communication - Risk of Eye and Skin Injuries
|
12/22/2015
|
|
8:30 PM
|
FDA MedWatch RSS Feed
|
Lasers that emit more than 5mW visible light power can cause irreversible eye injury of increasing severity as the power increases. High-powered laser pointers can irritate or even burn the skin.
Full Article
|
|
Smart Lipo: Recall - Undeclared Drug Ingredients
|
12/18/2015
|
|
7:00 PM
|
FDA MedWatch RSS Feed
|
Risk of increased blood pressure and/or pulse rate, may present significant risk for patients with a history of CAD, CHF, arrhythmias or stroke. Potentially serious GI disturbances, irregular heartbeat, and cancer with long-term use.
Full Article
|
|
Rosiglitazone-containing Diabetes Medicines: Drug Safety Communication - FDA Eliminates the Risk Evaluation and Mitigation Strategy (REMS)
|
12/16/2015
|
|
3:00 PM
|
FDA MedWatch RSS Feed
|
The REMS is no longer necessary to ensure that the benefits of rosiglitazone medicines outweigh their risks.
Full Article
|
|
Stella & Chewy's Voluntarily Recalls Frozen Dinner Morsel Products Due to Possible Health Risk
|
12/15/2015
|
|
10:17 PM
|
FDA Pet Health RSS Feed
|
Stella & Chewy's is voluntarily recalling four of its products sold in the U.S. and Canada due to concerns of a possible presence of Listeria monocytogenes. The recall affects a total of 990 cases (964 cases in the U.S and 26 cases in Canada).
Full Article
|
|
Bravo Recalls Select Chicken and Turkey Pet Foods Because of Possible Salmonella Health Risk.
|
12/11/2015
|
|
3:44 PM
|
FDA Pet Health RSS Feed
|
Bravo Pet Foods of Manchester, CT is recalling a select lot of Bravo Chicken Blend diet for dogs & cats with a best used by date of 11/13/16 due to concerns of the possible presence of Salmonella . Out of an abundance of caution, Bravo is also recalling three additional items that did not test positive for Salmonella , but were manufactured on the same day.
Full Article
|
|
Chariot Guiding Sheath by Boston Scientific: Recall - Risk of Shaft Separation
|
12/11/2015
|
|
2:30 PM
|
FDA MedWatch RSS Feed
|
Device failure could lead to embolism of device fragments, which could lead to obstruction of blood flow or additional intervention to remove a device fragment.
Full Article
|
|
Baclofen Active Pharmaceutical Ingredient from Taizhou Xinyou Pharmaceutical and Chemical: FDA Statement - FDA Warns of Potential Contamination
|
12/10/2015
|
|
2:00 AM
|
FDA MedWatch RSS Feed
|
The affected lots may potentially pose serious safety risks for U.S. patients who use or receive injectable drug products compounded with
the affected baclofen, especially when administered directly into the spinal column.
Full Article
|
|
Pink Bikini Dietary Supplement by Lucy's Weight Loss System: Recall - Undeclared Drug Ingredient
|
12/10/2015
|
|
12:00 AM
|
FDA MedWatch RSS Feed
|
Use of product may increase the risk of fatal heart attack or stroke, especially if used long term or taken in high doses, or if there is a history of heart disease.
Full Article
|
|
Inspiration LS, 5i and 7i Ventilator Systems by eVent Medical: Class I Recall - May Shut Down without Alarm
|
12/7/2015
|
|
6:40 PM
|
FDA MedWatch RSS Feed
|
If ventilator shuts down, the patient may not receive enough oxygen and could suffer serious adverse health consequences, including injury or death.
Full Article
|
|
SGLT2 Inhibitors: Drug Safety Communication - Labels to Include Warnings About Too Much Acid in the Blood and Serious Urinary Tract Infections
|
12/4/2015
|
|
7:40 PM
|
FDA MedWatch RSS Feed
|
Labeling changes describe risks of ketoacidosis, urosepsis and pyelonephritis.
Full Article
|
|
Lipo Escultura: Recall - Undeclared Drug Ingredients
|
12/4/2015
|
|
5:20 PM
|
FDA MedWatch RSS Feed
|
Use of product may increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.
Full Article
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OmniPod Insulin Management System by Insulet: Field Safety Notification - Reported Cases of Needle Mechanism Deployment Failure or Delay
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12/2/2015
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3:30 PM
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FDA MedWatch RSS Feed
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Interruption of insulin delivery may cause elevated blood glucose (hyperglycemia), which, if left untreated, can result in diabetic ketoacidosis.
Full Article
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Digital Temple Thermometer (DTT) by K-Jump Health Co., Ltd.: Recall - Inaccurate Temperature Display
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12/1/2015
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3:05 PM
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FDA MedWatch RSS Feed
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Manufacturing problem causes the affected thermometers to display temperatures that are lower than actual body temperatures, which may cause the user or caregiver of the user to delay or forego seeking appropriate care.
Full Article
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Blue Buffalo Voluntarily Recalls One Lot of Cub Size Wilderness Wild Chews Bones Due to Potential Salmonella Health Risk
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11/25/2015
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10:21 PM
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FDA Pet Health RSS Feed
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Blue Buffalo Company is voluntarily recalling one production lot of Cub Size Wilderness Wild Chews Bones. This is being done in an abundance of caution, as the product has the potential to be contaminated with Salmonella.
Full Article
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Intravascular Medical Devices: FDA Safety Communication - Lubricious Coating Separation
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11/23/2015
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2:00 PM
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FDA MedWatch RSS Feed
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Serious adverse events reported, including pulmonary embolism, pulmonary infarction, myocardial embolism, myocardial infarction, embolic stroke, tissue necrosis, and death.
Full Article
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CHS Inc. Issues Voluntary Recall of Certain Kountry Buffet and Provider Pellet Products Due to Excessive Copper
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11/17/2015
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8:29 PM
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FDA Pet Health RSS Feed
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CHS Inc. announced today it has implemented a voluntary recall of 50-pound packages of its Kountry Buffet 14% Text and Provider 15% Pellet, both for Mature Cattle, Horses, Goats & Sheep due to excessive levels of copper. No illnesses or deaths have been reported to date.
Full Article
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Iodine-containing Contrast Agents for Medical Imaging: Drug Safety Communication - Rare Cases of Underactive Thyroid in Infants
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11/17/2015
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3:00 PM
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FDA MedWatch RSS Feed
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Labels of all iodinated contrast media (ICM) products will include information about these cases. No changes to current prescribing, administration, or monitoring practices are recommended.
Full Article
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G5 Ventilator by Hamilton: Class I Recall - Ventilation and Alarm Failure
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11/14/2015
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4:55 AM
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FDA MedWatch RSS Feed
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If failure occurs, and the operator does not intervene, the patient may not receive enough oxygen and could suffer serious adverse health consequences, including injury or death.
Full Article
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Endoscope Washer/Disinfectors by Custom Ultrasonics: Safety Communication - FDA Recommends Health Care Facilities Transition to Alternate Reprocessing Methods
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11/13/2015
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7:10 PM
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FDA MedWatch RSS Feed
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Identified facility violations could result in an increased risk of infection transmission.
Full Article
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Halo, Purely for Pets® Issues Voluntary Recall of Sensitive Cat Turkey Dry Food Due to Mold
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11/12/2015
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5:42 PM
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FDA Pet Health RSS Feed
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Halo, Purely for Pets has initiated a limited, voluntary recall of its Spot’s Stew Sensitive Cat Turkey kibble with a Best By date of 09/04/2016 due to reports of mold. No other Halo products are affected. Consumers who have Spot’s Stew Sensitive Cat Turkey stamped “Best By 09/04/2016” should discontinue feeding, and return the remaining portion to any Halo retailer for a full refund or replacement.
Full Article
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Blue Buffalo Company, Ltd. Voluntarily Recalls Limited Production of Kitty Yums Chicken Recipe Cat Treats Due to the Presence of Propylene Glycol
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11/7/2015
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2:34 AM
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FDA Pet Health RSS Feed
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Blue Buffalo Company, Ltd. is voluntarily recalling a limited production of Blue Kitty Yums Chicken Recipe Cat Treats that may contain low levels of propylene glycol, which is not permitted by the FDA for use in cat food. Cats reacting to high doses of propylene glycol may exhibit signs of depression and may have a loss of coordination, muscle twitching, and excessive urination and thirst.
Full Article
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Plavix (clopidogrel): Drug Safety Communication - Long-term Treatment Does Not Change Risk of Death
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11/6/2015
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4:30 PM
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FDA MedWatch RSS Feed
|
FDA review determines that long-term use of clopidogrel does not increase/decrease overall risk of death in patients with, or at risk for, heart disease, and does not suggest that clopidogrel increases risk of cancer/death from cancer.
Full Article
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Myocardial Protection System (MPS) Delivery Sets by Quest Medical: Recall - Intermittent Seal Failure During Use
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10/29/2015
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6:20 PM
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FDA MedWatch RSS Feed
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Seal failure could result in patient blood loss.
Full Article
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Auvi-Q (epinephrine injection, USP): Recall - Potential Inaccurate Dosage Delivery
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10/29/2015
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12:50 PM
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FDA MedWatch RSS Feed
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If a patient experiencing a serious allergic reaction (i.e., anaphylaxis) does not receive the intended dose, there could be significant health consequences, including death.
Full Article
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Entacapone: Drug Safety Communication - FDA Review Found No Increased Cardiovascular Risks
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10/26/2015
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2:40 PM
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FDA MedWatch RSS Feed
|
Drug labels for Comtan and Stalevo will remain unchanged.
Full Article
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Salix Animal Health, LLC, Expands Voluntary Recall of Good N Fun Beefhide Chicken Sticks Dog Treats Due To Possible Salmonella Contamination
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10/24/2015
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12:56 AM
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FDA Pet Health RSS Feed
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Salix Animal Health,LLC is voluntarily expanding its recall of "Good 'n' Fun - Beefhide Chicken Sticks" because this product may be contaminated with Salmonella. Sampling conducted by the Georgia Department of Agriculture confirmed the presence of Salmonella in an additional lot of this product. In an abundance of caution, Salix Animal Health is expanding its original recall to include the tested lot and others made around the same timeframe.
Full Article
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Hepatitis C Treatments Viekira Pak and Technivie: Drug Safety Communication - Risk of Serious Liver Injury
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10/22/2015
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7:25 PM
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FDA MedWatch RSS Feed
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Cases of hepatic decompensation and liver failure in patients with underlying liver cirrhosis who were taking these medicines.
Full Article
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Kayexalate (sodium polystyrene sulfonate): Drug Safety Communication - FDA Requires Drug Interaction Studies
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10/22/2015
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4:58 PM
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FDA MedWatch RSS Feed
|
Prescribers and patients should consider separating Kayexalate dosing from other medications taken by mouth by at least 6 hours.
Full Article
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Downing Labs, LLC Sterile Compounded Products: Recall - Lack of Sterility Assurance
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10/21/2015
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12:00 PM
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FDA MedWatch RSS Feed
|
If there is a contamination in products intended to be sterile, patients are at risk of serious infections which may be life threatening.
Full Article
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Heater-Cooler Devices: FDA Safety Communication - Use of Devices Associated With Nontuberculous Mycobacteria Infections
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10/15/2015
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5:00 PM
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FDA MedWatch RSS Feed
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Potential for contaminated water to transmit bacteria through the air (aerosolize) through the device’s exhaust vent into the environment and to the patient.
Full Article
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Acetaminophen Tablets by Medline Industries: Recall - Mislabeling with Incorrect Strength
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10/15/2015
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11:20 AM
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FDA MedWatch RSS Feed
|
If the product is taken at the maximum labeled dose, or with other medications containing acetaminophen, it may lead to liver toxicity or liver failure.
Full Article
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Beacon Tip Angiographic Catheters by Cook Medical: Class 1 Recall - Catheter Tip May Slip or Separate
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10/13/2015
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7:40 PM
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FDA MedWatch RSS Feed
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UPDATED 10/13/2015. Expansion of the voluntary lot-specific recall. If this occurs, the tip could enter the patient?s bloodstream. This could cause serious injury to the patient and require additional medical intervention to retrieve the tip, or cause death.
Full Article
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Bioprosthetic Aortic Valves: FDA Notification - Reduced Leaflet Motion
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10/5/2015
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6:40 PM
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FDA MedWatch RSS Feed
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FDA is working to design clinical studies to fully evaluate reduced valve leaflet motion. At this time, FDA believes that bioprosthetic aortic valves remain reasonably safe and effective when used according to their approved indications.
Full Article
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K-9 Kraving Dog Food Has Announced a Voluntary Recall of Their Chicken Patties Dog Food Shipped Between July 13th - July 17th, 2015 Because The Product May Be Contaminated With Salmonella and Listeria monocytogenes
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10/5/2015
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3:48 PM
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FDA Pet Health RSS Feed
|
K-9 Kraving Dog 13th - July 17th, 2015 because these products may be contaminated with Salmonella and Listeria Food has announced a voluntary recall of their Chicken Patties Dog Food shipped between July Monocytogenes. Salmonella and Listeria Monocytogenes can affect animals eating the products and there is risk to humans from handling contaminated pet products, especially if they have not thoroughly washed their hands after having contact with the products or any surfaces exposed to these products.
Full Article
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Drug Products Intended to be Sterile by Chen Shwezin Inc., dba Park Compounding Pharmacy: FDA Statement - Lack of Sterility Assurance
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10/3/2015
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4:00 AM
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FDA MedWatch RSS Feed
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Administration of a non-sterile drug product intended to be sterile may result in serious and potentially life-threatening infections or death.
Full Article
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PROFEMUR Neck Varus/Valgus CoCr 8 Degree, Part number PHAC 1254 by MicroPort Orthopedics: Class I Recall - Unexpected Rate of Fractures After Surgery
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10/2/2015
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7:25 PM
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FDA MedWatch RSS Feed
|
Acute fracture and emergency revision surgery is a serious adverse health consequence and could lead to neurovascular damage, hematoma, hemorrhage, or death.
Full Article
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Salix Animal Health, LLC, Announces Voluntary Recall of One Lot of "Good 'N' Fun - Beefhide Chicken Sticks" Dog Treats Due to Possible Salmonella Contamination
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9/30/2015
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|
9:43 PM
|
FDA Pet Health RSS Feed
|
Salix Animal Health, LLC today announced it has initiated a voluntary recall of one lot of "Good 'n' Fun - Beefhide Chicken Sticks" because it may have the potential to be contaminated with Salmonella. Salmonella can affect animals eating the product and there is risk to humans from handling contaminated products.
Full Article
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Cranial Perforators With an Automatic Clutch Mechanism: Safety Communication - Failure to Disengage
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9/28/2015
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6:30 PM
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FDA MedWatch RSS Feed
|
Clutch mechanism may fail to disengage if proper use, patient considerations, and device selection are not followed in accordance with the manufacturer?s instructions for use.
Full Article
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OC RAW DOG Voluntarily Recalls Limited Number of Raw Frozen Dog Food Due to Potential Salmonella Health Risk
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9/28/2015
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2:27 PM
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FDA Pet Health RSS Feed
|
OC Raw Dog of Rancho Santa Margarita, CA is voluntarily recalling 640 lbs. of Chicken, Fish & Produce Raw Frozen Canine Formulation. This is being done in an abundance of caution, as the product has the potential to be contaminated with Salmonella.
Full Article
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Western Milling LLC Voluntarily Recalls Western Blend Horse Feed, Lot 5251 due to potential Monensin contamination.
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9/26/2015
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1:26 AM
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FDA Pet Health RSS Feed
|
Western Milling announced today that it has voluntarily recalled 50 lb bags of Western Blend horse feed, LOT 5251, manufactured on September 8, 2015. This voluntary recall was initiated by Western Milling after it learned that an ingredient in the feed in question may contain monensin, an ionophore.
Full Article
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Murphy Farm Hay and Feed Company Issues Recall of Alfalfa Hay Due to Possible Health Risk
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9/25/2015
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12:54 PM
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FDA Pet Health RSS Feed
|
Murphy Farm Hay and Feed Company of Louisburg North Carolina has initiated a voluntary limited recall of alfalfa hay due to potential Blister Beetle contamination. The product was offered for sale to consumers at the following two retail locations, Murphy Farm Hay and Feed in Louisburg, NC and Jones Farm Hay and Feed in Middlesex, NC.
Full Article
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Sterile Compounded Products by US Compounding, Inc: Recall - Lack of Sterility Assurance
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9/24/2015
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1:15 PM
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FDA MedWatch RSS Feed
|
If the sterility of a compounded preparation intended to be sterile is compromised, patients may be at risk.
Full Article
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Avycaz (ceftazidime and avibactam): Drug Safety Communication - Dose Confusion and Medication Errors
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9/22/2015
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2:30 PM
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FDA MedWatch RSS Feed
|
FDA revised the labels to indicate that each vial contains Avycaz 2.5 gram, equivalent to ceftazidime 2 gram and avibactam 0.5 gram.
Full Article
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Tramadol: Drug Safety Communication - FDA Evaluating Risks of Using in Children Aged 17 and Younger
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9/21/2015
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3:00 PM
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FDA MedWatch RSS Feed
|
Ultra-rapid metabolizers are more likely to have higher-than-normal amounts of the active form of the opioid in their blood after taking tramadol, which can result in breathing difficulty that may lead to death.
Full Article
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Freedom Driver System by SynCardia: Class I Recall - Part May Fail Causing Device to Stop Working
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9/18/2015
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4:48 PM
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FDA MedWatch RSS Feed
|
If the device stops pumping, the patient will lose consciousness almost immediately, which can lead to serious injury or death.
Full Article
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Ayurvedic Dietary Supplements by Shree Baidyanath: Consumer Advice Notice - Products Contain High Levels of Lead and/or Mercury
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9/17/2015
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11:00 PM
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FDA MedWatch RSS Feed
|
Testing has found that these products contain high levels of lead and/or mercury, which can cause serious health problems.
Full Article
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Reprocessed Flexible Bronchoscopes: FDA Safety Communication - Risk of Infection
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9/17/2015
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4:00 PM
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FDA MedWatch RSS Feed
|
If scope reprocessing procedure is not followed meticulously, the flexible bronchoscope can remain contaminated, potentially resulting in infection transmission from one patient to the next.
Full Article
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HeartMate II Left Ventricular Assist System (LVAS) by Thoratec Corporation: Urgent Medical Device Correction - Monitor the Backup Battery Expiration Date
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9/16/2015
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2:00 PM
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FDA MedWatch RSS Feed
|
Certain preventable advisory alarms may result in patients deciding to attempt a System Controller exchange.
Full Article
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Clozapine: Drug Safety Communication - FDA Modifies Monitoring for Neutropenia; Approves New Shared REMS Program
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9/15/2015
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6:03 PM
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FDA MedWatch RSS Feed
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Enhanced labeling explaining how to monitor patients for neutropenia/manage clozapine treatment. Approval of new, shared REMS.
Full Article
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Miracle Diet 30 and Miracle Rock 48 Capsules by The One Minute Miracle Inc.: Recall - Due to Presence of Undeclared Drug Products
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9/12/2015
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12:00 AM
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FDA MedWatch RSS Feed
|
FDA analysis revealing that these dietary supplements contain undeclared drug products making them unapproved drugs.
Full Article
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Invokana and Invokamet (canagliflozin): Drug Safety Communication - New Information on Bone Fracture Risk and Decreased Bone Mineral Density
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9/10/2015
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|
4:45 PM
|
FDA MedWatch RSS Feed
|
FDA added a new Warning and Precaution and revised the Adverse Reactions section of the Invokana and Invokamet drug labels.
Full Article
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Medistat RX Sterile Drug Products: Recall - Possible Contamination
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9/10/2015
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|
1:00 PM
|
FDA MedWatch RSS Feed
|
Administration of a non-sterile drug product intended to be sterile may result in serious and potentially life-threatening infections or death.
Full Article
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Compounded or Repackaged Drugs Stored in Becton-Dickinson Syringes: FDA Expands Warning
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9/8/2015
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10:30 PM
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FDA MedWatch RSS Feed
|
An interaction with the rubber stopper in certain lots of these syringes can cause some drugs stored in these syringes to lose potency if filled and not used immediately.
Full Article
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Puritan Bennett 980 Ventilators by Covidien: Class I Recall - Amount of Air Delivered May Be Lower Than Programmed
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9/2/2015
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|
2:56 PM
|
FDA MedWatch RSS Feed
|
A patient not receiving enough oxygen can result in possible injury or death.
Full Article
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Evita V500 and Babylog VN500 Ventilators by Dräger Medical: Class I Recall - Faulty Batteries
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9/2/2015
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|
2:20 PM
|
FDA MedWatch RSS Feed
|
If the ventilator shuts down, a patient may not receive necessary oxygen. This could cause patient injury or death.
Full Article
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DPP-4 Inhibitors for Type 2 Diabetes: Drug Safety Communication - May Cause Severe Joint Pain
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8/28/2015
|
|
5:30 PM
|
FDA MedWatch RSS Feed
|
New information added to the WARNINGS AND PRECAUTIONS section of the drug labeling.
Full Article
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OmniPod (Pod) Insulin Management System by Insulet Corporation: Recall - Possibility of a Higher Rate of Failure
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8/28/2015
|
|
11:40 AM
|
FDA MedWatch RSS Feed
|
Use may result in interruption of insulin delivery that can cause hyperglycemia, which, if left untreated, can result in diabetic ketoacidosis.
Full Article
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Alaris Medley Large Volume Pump (LVP) Frame Membrane by Elite Biomedical Solutions: Class I Recall - Frame Membrane May Allow Over or Under Delivery of Fluid by an Infusion Pump
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8/27/2015
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7:00 PM
|
FDA MedWatch RSS Feed
|
Over or under infusion of fluids to the patient has the potential to cause patient injury or death.
Full Article
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Alaris Syringe Pump by CareFusion: Class I Recall - Alarm Error May Cause Interruption of Therapy
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8/27/2015
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|
4:00 AM
|
FDA MedWatch RSS Feed
|
Failure of syringe module may result in a delay or interruption of therapy and can lead to serious patient injury or death.
Full Article
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Hudson RCI Sheridan Sher-I-Bronch Endobroncial Tube by Teleflex Medical: Class I Recall - Connector May Crack or Separate
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8/26/2015
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|
2:30 PM
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FDA MedWatch RSS Feed
|
The connector may break or separate on the tube. If this happens, the device may leak, causing the patient to not receive enough oxygen (hypoxia) or experience respiratory distress.
Full Article
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Refresh Lacri-Lube, Refresh P.M., FML 0.1 Percent and Blephamide 10 Percent/0.2 Percent by Allergan: Recall - Particulate Matter
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8/25/2015
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|
4:00 AM
|
FDA MedWatch RSS Feed
|
Potential adverse events may include eye pain, eye sewelling, ocular discomfort or eye irritation.
Full Article
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NORTHWEST FARM FOOD COOPERATIVE VOLUNTARILY RECALLS FROZEN RAW CAT FOOD DUE TO POSSIBLE SALMONELLA CONTAMINATION
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8/10/2015
|
|
9:50 PM
|
FDA Pet Health RSS Feed
|
Northwest Farm Food Cooperative of Burlington, WA, is voluntarily recalling frozen raw Cat Food with the code Jul12015B due to their potential to be contaminated with Salmonella.
Salmonella can affect animals eating the products and there is risk to humans from handling contaminated pet products.
Full Article
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Moses Lake Professional Pharmacy Issues Voluntary Recall of Unexpired Sterile Human and Veterinary Compounded Drugs Due to Lack of Sterility Assurance
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7/25/2015
|
|
2:54 AM
|
FDA Pet Health RSS Feed
|
Moses Lake Professional Pharmacy is voluntarily recalling human and veterinary sterile compounded drugs which are unexpired to the consumer level due to lack of sterility assurance.
The company has not received any reports of product contamination or adverse events to date, and is issuing this voluntary recall out of an abundance of caution following a recent inspection which identified an issue with sterility assurance.
Full Article
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Nature's Variety Issues Nationwide Voluntary Recall of Instinct? Raw Chicken Formula Because of Possible Salmonella Health Risk
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7/25/2015
|
|
2:23 AM
|
FDA Pet Health RSS Feed
|
Nature?s Variety has announced a voluntary recall of their Instinct? Raw Chicken Formula for dogs with a ?Best By? date of 04/27/16 because these products may be contaminated with Salmonella.?Salmonella can affect animals eating the products and there is risk to humans from handling contaminated pet products, especially if they have not thoroughly washed their hands after having contact with the products or any surfaces exposed to these products.
Full Article
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Bravo Recalls Select Chicken Pet Foods Because of Possible Salmonella Health Risk
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7/24/2015
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|
5:03 PM
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FDA Pet Health RSS Feed
|
Bravo Pet Foods of Manchester, CT is recalling select lots of Bravo Chicken pet foods for dogs and cats due to concerns of the possible presence of Salmonella.
The recall was initiated after routine testing by the New York State Department of Agriculture revealed the presence of Salmonella spp. Poly A contamination.
Full Article
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The Natural Dog Company, Inc. Recalls 12" Tremenda Sticks Because of Possible Salmonella Health Risk
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7/21/2015
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|
5:27 PM
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FDA Pet Health RSS Feed
|
The Natural Dog Company, Inc. of Windsor, CO, is recalling its 12oz bags of 12" Tremenda Sticks pet chews because they have the potential to be contaminated with Salmonella. Salmonella can affect animals eating the product and there is risk to humans from handling contaminated products, especially if they have not thoroughly washed their hands after having contact with the products or any surfaces exposed to these products.
Full Article
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0.9 Percent Sodium Chloride Injection, USP, 50mL and 100mL by Baxter: Recall - Particulate Matter
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7/20/2015
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|
4:00 AM
|
FDA MedWatch RSS Feed
|
Injecting a product containing particulate matter, in the absence of in-line filtration, may result in blockage of blood vessels, which can result in stroke, heart attack or damage to other organs.
Full Article
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Proglycem (diazoxide): Drug Safety Communication - Reports of Pulmonary Hypertension in Infants and Newborns
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7/16/2015
|
|
4:55 PM
|
FDA MedWatch RSS Feed
|
Monitor patients, especially those with risk factors for pulmonary hypertension, for signs of respiratory distress, including tachypnea, flaring nostrils, grunting, and chest wall retractions.
Full Article
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D&D Foods Issues Allergy Alert on Undeclared Milk and Wheat in Hy-Vee American Macaroni Salad
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7/16/2015
|
|
2:23 AM
|
FDA Pet Health RSS Feed
|
D&D Foods, Inc., based in Omaha, Nebraska, is recalling 3-pound containers of Hy-Vee American Macaroni Salad because they were incorrectly labeled and may contain undeclared milk and wheat (gluten). People who have an allergy or severe sensitivity to milk and wheat (gluten) run the risk of serious or life-threatening allergic reaction if they consume these products.
Full Article
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Calcium Chloride Intravenous Infusion 10% w/v 10mL Prefilled Syringe by Mylan: Market Withdrawal - Difficulties in Administration
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7/14/2015
|
|
4:00 AM
|
FDA MedWatch RSS Feed
|
Calcium Chloride Intravenous Infusion 10% w/v 10mL Prefilled Syringe by Mylan: Market Withdrawal - Difficulties in Administration
Full Article
|
|
Carnivore Meat Company, LLC Voluntarily Issues a Recall Two Batches of Raw Pet Treats
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7/10/2015
|
|
6:17 PM
|
FDA Pet Health RSS Feed
|
Carnivore Meat Company, LLC is recalling select products and lots of Carnivore Vital Essentials pet foods because they have the potential to be contaminated with Listeria monocytogenes. Healthy cats and dogs rarely become sick from Listeria monocytogenes. In humans, however, Listeria is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems
Full Article
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Non-aspirin Nonsteroidal Anti-inflammatory Drugs (NSAIDs): Drug Safety Communication - FDA Strengthens Warning of Increased Chance of Heart Attack or Stroke
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7/9/2015
|
|
6:30 PM
|
FDA MedWatch RSS Feed
|
Patients and health care professionals should remain alert for heart-related side effects the entire time that NSAIDs are being taken.
Full Article
|
|
Stella & Chewy?s Voluntarily Recalls Products Due to Possible Health Risk
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7/7/2015
|
|
1:48 PM
|
FDA Pet Health RSS Feed
|
Stella & Chewy?s is voluntarily recalling some of its products due to concerns of a possible presence of Listeria Monocytogenes. The recall was prompted by a positive test confirming Listeria monocytogenes in Chewy?s Chicken Freeze-Dried Dinner Patties for Dogs, 15 ounce, Lot #111?15, during routine surveillance testing by the Maryland Department of Agriculture.
Full Article
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Boulder Dog Food Company, L.L.C. Voluntarily Recalls Seven Bags of Turkey Sprinkles, 3 oz with A “Best By� Date of “05/18/16, 05/28/2016 and 05/30/2016� Due to Possible Salmonella Health Risk
|
7/2/2015
|
|
9:35 PM
|
FDA Pet Health RSS Feed
|
Boulder Dog Food Company, L.L.C. is voluntarily recalling the Turkey Sprinkles (3 oz.) with a “Best By� date of “05/18/16, 05/28/2016 and 05/30/2016�, a Lot Number of “743�, and a UPC Code of 899883001224 because the product has the potential of being contaminated with Salmonella. Salmonella can affect animals eating the product, and there is risk to humans who handle the product, especially if the handler does not thoroughly wash his or her hands after having contact with the Product or any surfaces exposed to the product.
Full Article
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Lifesaver Single Patient Use Manual Resuscitator by Teleflex Hudson RCI: Class I Recall - Intake Port Blockage
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7/2/2015
|
|
3:10 PM
|
FDA MedWatch RSS Feed
|
Recalled device may not deliver breathing support to the patient. A delay in treatment may potentially lead to patient injury or death.
Full Article
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Unapproved Prescription Ear Drop (Otic) Products: Not FDA Evaluated for Safety, Effectiveness and Quality
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7/1/2015
|
|
2:40 PM
|
FDA MedWatch RSS Feed
|
Unapproved products may be contaminated or manufactured incorrectly, which could result in patients receiving the wrong dose, even when administered according to the labeled directions for use.
Full Article
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Daytrana Patch (methylphenidate transdermal system): Drug Safety Communication - Permanent Skin Color Changes
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6/24/2015
|
|
4:10 PM
|
FDA MedWatch RSS Feed
|
New warning added to drug label to describe risk of chemical leukoderma.
chemical leukoderma, have been associated with the use of the Daytrana patch.
Full Article
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HeartWare Ventricular Assist System: Class I Recall – Updated with Multiple Reasons for Recall
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6/22/2015
|
|
4:35 PM
|
FDA MedWatch RSS Feed
|
FDA will update recall with new information as it becomes available.
Full Article
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M/L Taper with Kinectiv Technology Prosthesis by Zimmer: Class I Recall - Higher than Expected Levels of Manufacturing Residues
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6/20/2015
|
|
1:00 AM
|
FDA MedWatch RSS Feed
|
Can cause serious adverse health issues including allergic reactions, pain, infections, or death.
Full Article
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Boulder Dog Food Company, L.L.C. Voluntarily Recalls Ten Bags of Chicken Sprinkles, 3 oz. With A ?Best By? Date of ?05/04/16? Due to Possible Salmonella Health Risk
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6/19/2015
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8:33 PM
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FDA Pet Health RSS Feed
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Boulder Dog Food Company, L.L.C. is voluntarily recalling the Chicken Sprinkles (3 oz.) with a ?Best By? date of ?05/04/16?, a Lot Number of ?998?, and a UPC Code of 899883001231 (the ?Product?), because the Product has the potential of being contaminated with Salmonella.?Salmonella can affect animals eating the Product, and there is risk to humans who handle the Product, especially if the handler does not thoroughly wash his or her hands after having contact with the Product or any surfaces exposed to the Product.
Full Article
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HeartWare Ventricular Assist System: Class I Recall - Damaged Alignment Guides or Connection Pins May Cause Pump to Stop
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6/16/2015
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3:55 PM
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FDA MedWatch RSS Feed
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An interruption in electrical connection would cause the pump to stop, which could cause serious patient injury or death.
Full Article
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Potiga (ezogabine): Drug Safety Communication - FDA Determines 2013 Labeling Adequate to Manage Risks of Retinal Abnormalities, Potential Vision Loss, and Skin Discoloration
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6/16/2015
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2:00 PM
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FDA MedWatch RSS Feed
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Health care professionals should continue to follow the recommendations provided in the BOXED WARNING, FDA?s most serious type of warning, and the WARNINGS AND PRECAUTIONS and INDICATIONS AND USAGE sections of the labeling.
Full Article
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Ainsworth Pet Nutrition Voluntarily Recalls Five Nutrish® Wet Cat Food Varieties For Potentially Elevated Vitamin D Levels
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6/5/2015
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1:24 PM
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FDA Pet Health RSS Feed
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Ainsworth Pet Nutrition of Meadville, PA is voluntarily recalling five varieties of Rachael Ray™ Nutrish® wet cat food, including Ocean Fish-a-licious, Lip Smackin’ Sardine & Mackerel, Ocean Fish & Chicken Catch-iatore, Tuna Purrfection, and certain lot codes of Paw Lickin’ Chicken & Liver due to potentially elevated levels of vitamin D. Symptoms of excessive vitamin D consumption usually develop within 12-36 hours after ingestion and may include vomiting or diarrhea, increased thirst and urination, and muscle tremors or seizures.
Full Article
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Vascu-Guard Peripheral Vascular Patch by Baxter: Recall - Difficulty Distinguishing the Smooth from Rough Surface
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6/3/2015
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4:00 AM
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FDA MedWatch RSS Feed
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Incorrect orientation of the patch with the rough side toward the bloodstream may increase the risk of vessel thrombosis and/or embolism. Posted 06/03/2015
Full Article
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Unintentional Injection of Soft Tissue Filler into Blood Vessels in the Face: FDA Safety Communication - Risk of Serious Patient Injury
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5/28/2015
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3:10 PM
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FDA MedWatch RSS Feed
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Risk of embolization, which can cause vision impairment, blindness, stroke and damage and/or death of the skin and underlying facial structures.
Full Article
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Avea Ventilator by CareFusion: Recall - Potential Malfunction of Pressure Transducer
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5/27/2015
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5:00 PM
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FDA MedWatch RSS Feed
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Ventilator may activate false Extended High Ppeak or Circuit Occlusion audio and visual alarms, open the safety valve and stop ventilating.
Full Article
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Zerbaxa (ceftolozane and tazobactam): Drug Safety Communication - FDA Cautions about Dose Confusion and Medication Errors
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5/20/2015
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4:00 AM
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FDA MedWatch RSS Feed
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Can lead to to administration of more drug than was prescribed.
Full Article
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OC Raw Dog Recalls Turkey & Produce Raw Frozen Canine Formulation Because of Possible Salmonella Health Risk
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5/16/2015
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12:48 AM
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FDA Pet Health RSS Feed
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OC Raw Dog of Rancho Santa Margarita, CA is voluntarily recalling 2055 lbs. of Turkey & Produce Raw Frozen Canine Formulation, because it has the potential to be contaminated with Salmonella. An organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.
Full Article
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SGLT2 inhibitors: Drug Safety Communication - FDA Warns Medicines May Result in a Serious Condition of Too Much Acid in the Blood
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5/15/2015
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3:00 PM
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FDA MedWatch RSS Feed
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High levels of blood acids called ketones may require hospitalization. Posted 05/15/2015
Full Article
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LifeCare PCA3 and PCA5 Infusion Pump Systems by Hospira: FDA Safety Communication - Security Vulnerabilities
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5/13/2015
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4:00 AM
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FDA MedWatch RSS Feed
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An unauthorized user with malicious intent could access the pump remotely and modify the dosage it delivers, which could lead to over- or under-infusion of critical therapies.
Full Article
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Tiger Paw System II by Maquet Medical Systems: Class I Recall - May Cause Tears and Bleeding in Heart Tissue
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5/7/2015
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4:50 PM
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FDA MedWatch RSS Feed
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Possibility of a tear on the left atrial wall during use of the device.
Full Article
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Adrucil (fluorouracil Injection, USP) 5 g/100 mL (50 mg/mL): Recall - Particulate Matter
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5/5/2015
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12:20 PM
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FDA MedWatch RSS Feed
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Administration of product with particulate matter has potential to result in inflammation, allergic reactions, or blockage of blood vessels, which may be life-threatening if vital organs are affected.
Full Article
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Kent Nutrition Group, Inc. Initiates Recall of Poultry Feed
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5/4/2015
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2:02 PM
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FDA Pet Health RSS Feed
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Kent Nutrition Group, Inc. is recalling one lot of its Blue Seal Home Fresh Starter Amp Medicated Poultry Feed. The recall is being implemented due to the discovery of excess salt in the feed concerning lot number 1015072.
Full Article
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Mammograms at Coastal Diagnostic Center in Pismo Beach, California: FDA Safety Communication - Quality Problems
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4/30/2015
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6:30 PM
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FDA MedWatch RSS Feed
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Patients may need a repeat mammogram or additional medical follow-up.
Full Article
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TFH Publications, Inc./Nylabone Products Recalls Puppy Starter Kit Due To Possible Salmonella Health Risk
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4/26/2015
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3:43 AM
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FDA Pet Health RSS Feed
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TFH Publications, Inc./Nylabone Products, of Neptune, NJ is recalling one lot of its 1.69 oz. package of the Puppy Starter Kit dog chews, because they have the potential to be contaminated with Salmonella. Salmonella can affect animals ingesting the product and there is risk to humans from handling contaminated products, especially if they have not thoroughly washed their hands after having contact with the products or any surfaces exposed to these products.
Full Article
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Injectable Products by Mylan: Recall - Presence of Particulate Matter
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4/24/2015
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6:45 PM
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FDA MedWatch RSS Feed
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Administration of a sterile injectable that has foreign particulates has the potential of severe health consequences.
Full Article
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Bupivacaine HCl Injection by Hospira: Recall - Iron Oxide Particulate In Glass Vials
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4/24/2015
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2:00 PM
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FDA MedWatch RSS Feed
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Injected particulate may result in local inflammation, low-level allergic or immune responses, granuloma formation or mechanical irritation of tissue.
Full Article
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Hospira Issues A Voluntary Nationwide Recall Of One Lot Of Bupivacaine HCl Injection Due To Potential Iron Oxide Particulate In Glass Vials
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4/24/2015
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1:00 PM
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FDA Pet Health RSS Feed
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Hospira, Inc., (NYSE: HSP) has announced today it is issuing a voluntary recall of one lot of Preservative-Free Bupivacaine HCl Injection, USP, 0.5% (5 mg/mL), 30 mL Single-dose (NDC: 0409-1162-02, Lot 38-515-DK, Expiry 1FEB2016) due to one confirmed customer complaint of orange and black, visible particles embedded and free floating within a single-dose glass teartop vial. The particles were identified as iron oxide. This recall is being carried out to the user level (both human and veterinary).
Full Article
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Ebola Virus One-Step Test Kits by LuSys Laboratories: Class I Recall - Not Cleared for Marketing
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4/23/2015
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4:00 AM
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FDA MedWatch RSS Feed
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The results obtained from these test kits have not been demonstrated to be accurate and should not be used as diagnostic tests for Ebola infection. Posted 04/23/2015
Full Article
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Mucinex Fast-MAX Products: Recall - Incorrect Labeling
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4/22/2015
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7:10 PM
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FDA MedWatch RSS Feed
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Consumers could take a product with undeclared levels of acetaminophen, dextromethorphan, guaifenesin, phenylephrine and/or diphenhydramine.
Full Article
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Flurbiprofen-Containing Topical Pain Medications: FDA Alert - Illnesses and Deaths in Pets Exposed to Prescription Topical Pain Medication
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4/17/2015
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4:15 PM
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FDA MedWatch RSS Feed
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Evidence of NSAID toxicity in the pets exposed to flurbiprofen and died.
Full Article
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VV13F Reinforced Dual Lumen ECMO Catheters by OriGen Biomedical: Recall - Potential for Separation of Tube from Hub
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4/16/2015
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1:00 PM
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FDA MedWatch RSS Feed
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Separation could result in required intervention to prevent permanent impairment or damage.
Full Article
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Intravenous (IV) Solutions (Select Lots) by Baxter: Recall - Potential Presence of Particulate Matter
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4/10/2015
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2:40 PM
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FDA MedWatch RSS Feed
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Particles in IV solutions may cause: local vein irritation, inflammatory reaction, aggravation of preexisting infections, allergic reactions, and systemic embolization.
Full Article
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North Carolina Board of Pharmacy Announces a Recall of All Lots of Non- Sterile and Sterile Products Compounded, Repackaged, and Distributed by Prescription Center Between September 10, 2014 and March 10, 2015 Due to Lack of Sterility, Potency, and St...
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4/3/2015
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12:49 AM
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FDA Pet Health RSS Feed
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The North Carolina Board of Pharmacy has ordered a recall for all lots of non-sterile and sterile products compounded, repackaged and distributed by Prescription Center Pharmacy located at 915 Hay Street, Fayetteville, NC, between September 10, 2014, and March 10, 2015.
Full Article
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Products from Prescription Center Pharmacy in Fayetteville, N.C.: Recall - Lack of Sterility Assurance
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4/2/2015
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3:45 PM
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FDA MedWatch RSS Feed
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Human and veterinary drug products made by the Prescription Center have been distributed nationwide and to Canada.
Full Article
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Feraheme (ferumoxytol): Drug Safety Communication – Warnings Strengthened and Prescribing Instructions Changed
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3/31/2015
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11:00 AM
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FDA MedWatch RSS Feed
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Risk of potentially life-threatening allergic reactions.
Full Article
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Duodenoscope Model TJF-Q180V by Olympus: FDA Safety Communication - New Reprocessing Instructions Validated
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3/26/2015
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7:00 PM
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FDA MedWatch RSS Feed
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If not properly reprocessed patients may be exposed to serious infections.
Full Article
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Mammograms at Richard D. Adelman M.D. in Raleigh, North Carolina: FDA Safety Communication - Quality Problems
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3/24/2015
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7:10 PM
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FDA MedWatch RSS Feed
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The facility may not perform mammography due to the revocation of its accreditation.
Full Article
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Hepatitis C Treatments Containing Sofosbuvir in Combination With Another Direct Acting Antiviral Drug: Drug Safety Communication - Serious Slowing of Heart Rate When Used With Antiarrhythmic Drug Amiodarone
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3/24/2015
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4:50 PM
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FDA MedWatch RSS Feed
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Postmarketing cases of serious and life-threatening symptomatic bradycardia, as well as one fatal cardiac arrest and cases requiring pacemaker insertion, have been reported.
Full Article
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Zyprexa Relprevv (olanzapine pamoate): Drug Safety Communication - FDA Review of Study Sheds Light on Two Deaths Associated with the Injectable Schizophrenia Drug
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3/23/2015
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6:00 PM
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FDA MedWatch RSS Feed
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FDA is unable to exclude the possibility that the deaths were caused by rapid, but delayed, entry of the drug into the bloodstream following intramuscular injection.
Full Article
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Over-the-Counter Asthma Products Labeled as Homeopathic: FDA Statement - Consumer Warning About Potential Health Risks
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3/19/2015
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4:00 PM
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FDA MedWatch RSS Feed
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If asthma is not appropriately treated and managed, patients may be at risk for life-threatening asthma attacks.
Full Article
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Primal Pet Foods Voluntarily Recalls A Single Lot of Raw Frozen Cat Food
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3/14/2015
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12:12 AM
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FDA Pet Health RSS Feed
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Primal Pet Foods is voluntarily recalling a single batch production code of Feline Turkey Raw Frozen Formula 3-pound bag. FDA tested product in response to a single consumer complaint. Primal Pet Foods was alerted by FDA that the testing of two bags of this lot resulted in a low thiamine level. Neither FDA nor Primal have received any other reports concerning Thiamine in Primal products. No other product manufactured by Primal Pet Foods is involved in this voluntary recall.
Full Article
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Lactated Ringer's Irrigation, 3000mL by Hospira: Recall - Mold Contamination
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3/12/2015
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11:30 AM
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FDA MedWatch RSS Feed
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Contaminated solution used on a patient may result in bacteremia, sepsis, septic shock and endocarditis, and death may result.
Full Article
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Treanda (bendamustine hydrochloride) Solution by Teva: FDA Statement - Not Compatible with Closed System Transfer Devices, Adapters, and Syringes Containing Polycarbonate or Acrylonitrile-Butadiene-Styrene
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3/11/2015
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12:30 AM
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FDA MedWatch RSS Feed
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Can lead to device failure, possible product contamination, and potential serious adverse health consequences.
Full Article
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Chantix (varenicline): Drug Safety Communication - FDA Updates Label to Include Potential Alcohol Interaction
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3/9/2015
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10:00 PM
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FDA MedWatch RSS Feed
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Rare risk of seizures, and studies of side effects on mood, behavior, or thinking. Posted 03/09/2015
Full Article
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Magnesium Sulfate in 5 Percent Dextrose Injection by Hospira: Recall - Incorrect Barcode Labeling
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3/6/2015
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7:10 PM
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FDA MedWatch RSS Feed
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Potential for delay in treatment of magnesium sulfate in 5% dextrose, that can result in life-threatening seizures, stroke, cerebral hemorrhage and maternal death, and attendant risks to the fetus, including fetal demise.
Full Article
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Plum A+ and Plum A+3 Infusion Systems by Hospira: Class I Recall - Alarm Volume Failure
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3/6/2015
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3:30 PM
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FDA MedWatch RSS Feed
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Risk of injury or death resulting from prolonged interruption in therapy.
Full Article
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0.9 Percent Sodium Chloride Injection, USP, 250 mL VisIV Container by Hospira: Recall - Particulate Matter
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3/6/2015
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1:42 PM
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FDA MedWatch RSS Feed
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Injected particulate material may result in localized inflammation, phlebitis, allergic reaction, granuloma formation or microembolic effects, and/or low-level allergic response.
Full Article
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Testosterone Products: Drug Safety Communication - FDA Cautions About Using Testosterone Products for Low Testosterone Due to Aging; Requires Labeling Change to Inform of Possible Increased Risk of Heart Attack And Stroke
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3/3/2015
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4:00 PM
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FDA MedWatch RSS Feed
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FDA requiring manufacturers to change labeling to clarify the approved uses of these medications, and to add information about a possible increased risk of heart attacks and strokes in patients taking testosterone.
Full Article
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HeartWare Ventricular Assist System Controllers: Recall - Clinical Trial Controllers Susceptible to Electrostatic Discharge
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2/27/2015
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3:40 PM
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FDA MedWatch RSS Feed
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Electrostatic discharge event could result in a pump stop, which could cause serious injury or death.
Full Article
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Colistimethate for Injection USP, 150 mg and Rifampin for Injection USP, 600 mg/vial by Heritage Pharmaceuticals: Recall - Lack of Sterility Assurance
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2/25/2015
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8:45 PM
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FDA MedWatch RSS Feed
|
Administration of non-sterile injection products may result in a site-specific or systemic infection, with the potential to cause hospitalization, permanent organ damage, or death.
Full Article
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Magnetic Resonance Imaging (MRI) Systems with Magnet Rundown Unit by GE Healthcare: Class I Recall - Potential Disabling of the Magnet Rundown Unit
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2/25/2015
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8:00 PM
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FDA MedWatch RSS Feed
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Risk of life-threatening injuries or death if a metal object is brought into the magnetic field.
Full Article
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MAQUET Servo Humidifier 163 by Teleflex Medical: Class I Recall - Cracks in Connector Tubes May Lead to Leak Failures
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2/25/2015
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5:00 AM
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FDA MedWatch RSS Feed
|
Cracks may prevent device from delivering sufficient support to the patient. This may potentially cause serious injury or death.
Full Article
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Atracurium Besylate Injection by Sagent Pharmaceuticals: Recall - Potential Impact on Product Sterility
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2/24/2015
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6:15 PM
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FDA MedWatch RSS Feed
|
Has the potential to result in infections, which could be fatal, especially in patients who are immunocompromised.
Full Article
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Purina Animal Nutrition LLC Recalls One Lot of DuMOR Sheep Formula, 50 lbs. Bags Due to Potentially High Level of Copper; Distributed only in Florida
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2/24/2015
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4:45 PM
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FDA Pet Health RSS Feed
|
Purina Animal Nutrition LLC has initiated a limited voluntary recall of DuMOR Sheep Formula in Florida due to the potential for a
higher-than-acceptable level of copper, which can cause health issues and potential mortality. There has been one report of sheep mortality associated with the single lot that is being recalled.
Full Article
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Endoscopic Retrograde Cholangiopancreatography (ERCP) Duodenoscopes: FDA Safety Communication - Design May Impede Effective Cleaning
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2/19/2015
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6:00 PM
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FDA MedWatch RSS Feed
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Patients may be exposed to serious infections.
Full Article
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Tuffy's Pet Foods, Inc. Issues Voluntary Recall of a Limited Quantity of Nutrisca Dry Dog Food Because of Possible Health Risk
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2/11/2015
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9:42 PM
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FDA Pet Health RSS Feed
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Tuffy's Pet Foods, Inc. of Perham, MN is voluntarily recalling specific lots of 4 lb. bags of Nutrisca Chicken and Chick Pea Recipe Dry Dog Food because they have the potential to be contaminated with Salmonella. Tuffy's manufactured the product for Nutrisca.
Full Article
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Pet International Inc. Recalls 6” Beef Trachea Pet Treat Because of Possible Salmonella Health Risk
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2/11/2015
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8:25 PM
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FDA Pet Health RSS Feed
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Pet International of Miami, Florida is recalling 1500 units of 6” Beef Trachea Pet Treat because it has the potential to be contaminated with Salmonella. Salmonella can affect animals (i.e. dogs) eating the products and there is risk to humans from handling contaminated pet products, especially if they have not thoroughly washed their hands after having contact with the products or any surfaces exposed to these products.
Full Article
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Ketorolac Tromethamine Injection by Hospira: Recall - Particulate in Glass Vials
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2/11/2015
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6:05 PM
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FDA MedWatch RSS Feed
|
Administration of particulates has the potential for localized inflammation, allergic reaction, granuloma formation, microembolic effects, or delay of therapy.
Full Article
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Trellis 6 and Trellis 8 Peripheral Infusion Systems by Covidien: Class I Recall - Balloon Inflation Ports Mislabeled
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2/11/2015
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4:40 PM
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FDA MedWatch RSS Feed
|
The physician using the device may deflate the balloons in the incorrect order. If this happens, there is a potential for blood clots to dislodge and move into the lungs.
Full Article
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J.J. Fuds, Inc. Expands Recall of Pet Food Because of Possible Health Risk
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2/6/2015
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6:52 PM
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FDA Pet Health RSS Feed
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J.J. Fuds in Valparaiso, IN is expanding their recall to include all lots and products of J.J. Fuds Chicken Tender Chunks, Beef Tender Chunks and Duckling Tender Chunks Pet Food because it has the potential to be contaminated with Listeria monocytogenes and or Salmonella, organisms which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.
Full Article
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Grill-Phoria LLC Recalls Big Bark All Natural Beef Jerky Treats for Dogs Because of Possible Salmonella Health Risk
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1/31/2015
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1:10 AM
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FDA Pet Health RSS Feed
|
Grill-Phoria LLC of Loveland, Colorado is recalling approximately 200, 3.5 oz bags of Big Bark All Natural Beef Jerky Treats for Dogs because they have the potential to be contaminated with Salmonella. These bags were distributed and manufactured between September 20, 2014 through January 2, 2015, and do not have lot codes.
Full Article
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J.J. Fuds, Inc. Issues Recall of Pet Food Because of Possible Health Risk
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1/23/2015
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10:02 PM
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FDA Pet Health RSS Feed
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J.J. Fuds in Valparaiso, IN is recalling a select lot and product of J.J. Fuds Chicken Tender Chunks Pet Food because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.
Full Article
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Cox Veterinary Laboratory, Inc. Issues Voluntary Recall of “Gastroade Xtra”
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1/23/2015
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|
9:54 PM
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FDA Pet Health RSS Feed
|
Cox Veterinary Laboratory, Inc. is
voluntarily recalling the lots of Gastroade Xtra identified below down to the consumer level
distributed nationwide. Gastroade Xtra was previously marketed by Cox Veterinary Laboratory as
an OTC drug for use in horses, and contains Omeprazole.
Full Article
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0.9 Percent Sodium Chloride Injection, USP, 250 mL by Hospira : Recall - Particulate Matter
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1/23/2015
|
|
3:48 PM
|
FDA MedWatch RSS Feed
|
Injected particulate material may result in local inflammation, phlebitis, and/or low-level allergic response.
Full Article
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Bone Graft Substitutes Containing Recombinant Proteins or Synthetic Peptides in Patients Under Age 18: FDA Safety Communication - Reports of Serious Injuries
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1/21/2015
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4:00 PM
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FDA MedWatch RSS Feed
|
Risk of excess bone growth, fluid accumulation, inhibited bone healing, and swelling.
Full Article
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Oma's Pride Recalls Purr Complete Feline Poultry Meal because of Possible Salmonella Health Risk
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1/17/2015
|
|
1:55 AM
|
FDA Pet Health RSS Feed
|
Oma's Pride of Avon, CT is recalling Purr-Complete Feline Poultry Meal because it has the potential to be contaminated with Salmonella.????Salmonella can affect animals eating the products and there is risk to humans from handling contaminated pet products, especially if they have not thoroughly washed their hands after having contact with the products or any surfaces exposed to these products.
Full Article
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Simulated IV Solutions from Wallcur: CDER Statement- FDA's Investigation into Patients being Injected
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1/14/2015
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5:00 AM
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FDA MedWatch RSS Feed
|
Adverse events include fever, chills, tremors and headache,and there is one death associated with the use of these products.
Full Article
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Prescription and Over-the-Counter (OTC) Pain Medicines: Drug Safety Communication - FDA Review of Possible Risks of Pain Medicine Use During Pregnancy
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1/9/2015
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5:20 PM
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FDA MedWatch RSS Feed
|
Pregnant women urged to discuss all medicines with their health care professionals before using them.
Full Article
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Barkworthies Issues Nationwide Recall of Chicken Vittles Dog Chews
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1/2/2015
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5:43 PM
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FDA Pet Health RSS Feed
|
Barkworthies of Richmond, VA is recalling select lots of Barkworthies Chicken Vittles dog chews because they have the potential to be contaminated with Salmonella. Salmonella can affect animals eating the products and there is risk to humans from handling contaminated pet products, especially if they have not thoroughly washed their hands after having contact with the products or any surfaces exposed to these products.
Full Article
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Virazole (Ribavirin Powder For Solution) by Valeant Pharmaceutical North America, LLC: Recall- Due to Microbial Contamination
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1/2/2015
|
|
1:36 PM
|
FDA MedWatch RSS Feed
|
Inhalation of a non-sterile product with microbial contamination into the airways could increase the risk of respiratory infection.
Full Article
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Jump Your Bones, Inc. Recalls Roo Bites (Cubes) Pet Treats
|
12/31/2014
|
|
9:04 PM
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FDA Pet Health RSS Feed
|
Jump Your Bones, Inc. of Boca Raton, Florida is voluntarily recalling Jump Your Bones brand name Roo Bites (Cubes) because it has the potential to be contaminated with Salmonella. No pet or consumer illnesses from this product have been reported to date.
Full Article
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KimVent Microcuff Subglottic Suctioning Endotracheal Tubes by Halyard Health: Class I Recall - Component May Detach During Use
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12/31/2014
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|
6:20 PM
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FDA MedWatch RSS Feed
|
An air leak between cuff and tracheal wall may reduce the amount of air that reaches the lungs. Use of this recalled product could cause serious health risks, including delayed patient treatment, breathing difficulties, and death.
Full Article
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Nellcor Puritan Bennett 980 Ventilator System by Covidien: Class I Recall - Component Failure May Cause Burning Odor
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12/31/2014
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4:30 PM
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FDA MedWatch RSS Feed
|
Problems in the manufacturing process may lead to unexpected need to stop the ventilator and transfer the patient to another ventilator.
Full Article
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IV Solutions from Wallcur of San Diego: CDER Statement - FDA Warns Health Care Professionals Not to Inject Patients
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12/31/2014
|
|
12:00 AM
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FDA MedWatch RSS Feed
|
There have been reports of serious adverse events associated with the use of certain of these products.
Full Article
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Burkmann Feeds, Danville, KY RECALLS 656-Layer Ration 20% Pellets Because of Possible Monensin Sodium Contamination
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12/30/2014
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5:14 PM
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FDA Pet Health RSS Feed
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Burkmann Feeds is recalling its 50lb bags of Layer Ration 20% Pellets lot # 2090341 because they have the potential to be contaminated with Monensin Sodium, an ionophore that is not approved for use in layer rations. Consumption of Monensin Sodium in chickens may cause sickness, lethargic birds and possible mortality.
Full Article
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Caramel Apples: Warning - Illnesses, Including Deaths, Linked to Listeria Monocytogenes Contamination
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12/26/2014
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1:45 AM
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FDA MedWatch RSS Feed
|
Listeriosis can be fatal, especially in certain high-risk groups, including the elderly, and people with weakened immune systems and certain chronic medical conditions (such as cancer).
Full Article
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Mitoxantrone by Hospira: Recall - Confirmed Subpotency and Out-Of-Specification
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12/24/2014
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1:20 AM
|
FDA MedWatch RSS Feed
|
Potential for decreased potency which can lead to decreased effectiveness, additional dosing, and the potential for cumulative impurity toxicity requiring medical intervention.
Full Article
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B-Lipo Capsules by Bethel Nutritional Consulting, Inc.: Recall - Undeclared Drug Ingredient
|
12/22/2014
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|
5:00 AM
|
FDA MedWatch RSS Feed
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Serious adverse events, which may be life-threatening, include damage to the heart valve, or
serotonin syndrome particularly if taken with other medications that work similarly.
Full Article
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SLIM-K Capsules by Bethel Nutritional Consulting, Inc.: Recall - Undeclared Drug Ingredients
|
12/22/2014
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|
5:00 AM
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FDA MedWatch RSS Feed
|
Can increase blood pressure and/or pulse rate, interact in life threatening ways with other medications, casue serious GI disturbances, irregular heartbeat, and cancer with long-term use.
Full Article
|
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Tristar Equine Issues Voluntary Recall of Gastrotec
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12/17/2014
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3:17 PM
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FDA Pet Health RSS Feed
|
Tristar Equine Marketing, LLC is voluntarily recalling all lots of Gastrotec down to the consumer level. Gastrotec was previously marketed by Tristar as an OTC drug for use in horses, and contains a combination of Omeprazole and Misoprostol.
Full Article
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0.9 Percent Sodium Chloride Injection USP in 100 mL MINI-BAG PLUS Container by Baxter: Recall - Particulate Matter
|
12/16/2014
|
|
2:30 PM
|
FDA MedWatch RSS Feed
|
Intravenous administration of a solution containing particulate matter may lead to local vein irritation, inflammatory reaction, aggravation of preexisting infections, allergic reactions, and systemic embolization.
Full Article
|
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Ziprasidone (Marketed as Geodon and Generics): Drug Safety Communication - Rare But Potentially Fatal Skin Reactions
|
12/11/2014
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6:50 PM
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FDA MedWatch RSS Feed
|
Symptoms may include a rash that can spread to all parts of the body, fever, swollen lymph nodes, and inflammation of organs such as the liver, kidney, lungs, heart, or pancreas.
Full Article
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Lakeland Animal Nutrition Issues Voluntary Horse Feed Recall
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12/4/2014
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5:05 PM
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FDA Pet Health RSS Feed
|
Lakeland Animal Nutrition has been informed that certain horse feeds manufactured by the company in Lakeland, Florida and distributed within the state of Florida may contain monensin and lasalocid. Serious injury or death can occur in horses consuming feeds containing monensin and/or lasalocid.
Full Article
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Heart Sync Inc. Multi-function Defibrillation Electrodes: Device Correction - Connector Incompatibility with Philips FR3 and FRx Defibrillator Units
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12/3/2014
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|
8:00 PM
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FDA MedWatch RSS Feed
|
May result in a delay in therapy.
Full Article
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Siemens Healthcare Diagnostics, Rapid Gram Negative Combo Panels: Class I Recall - May Produce Incorrect Results
|
12/2/2014
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|
12:30 PM
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FDA MedWatch RSS Feed
|
Using these recalled devices may cause ineffective patient treatment.
Full Article
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CONMED PadPro and R2 Multi-function Defibrillation Electrodes: Device Correction - Connector Compatibility Issue With Philips FR3 and FRx Defibrillator Units
|
11/26/2014
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|
6:40 PM
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FDA MedWatch RSS Feed
|
May result in a delay in therapy.
Full Article
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Slim-Vie: Public Notification - Undeclared Drug Ingredient
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11/26/2014
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|
2:52 PM
|
FDA MedWatch RSS Feed
|
Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.
Full Article
|
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Tecfidera (dimethyl fumarate) by Biogen Idec: Drug Safety Communication - Case of Rare Brain Infection PML Reported
|
11/25/2014
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|
6:15 PM
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FDA MedWatch RSS Feed
|
Symptoms of PML may include: progressive weakness on one side of the body or clumsiness of limbs; disturbance of vision; and changes in thinking, memory and orientation. The progression of deficits can lead to severe disability or death.
Full Article
|
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Natura Pet Recalls 5 Lots of Dry Cat and Dry Ferret Food due to Vitamin Insufficiency
|
11/25/2014
|
|
12:11 AM
|
FDA Pet Health RSS Feed
|
Natura Pet Products has initiated a limited, voluntary recall of certain dry cat and dry ferret food lots produced in its Fremont, Nebraska facility. Due to a formulation error, these products contain insufficient levels of vitamins and excess minerals.
Full Article
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Super Extreme Accelerator: Public Notification - Undeclared Drug Ingredient
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11/24/2014
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|
6:40 PM
|
FDA MedWatch RSS Feed
|
Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.
Full Article
|
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Black Storm: Public Notification - Undeclared Drug Ingredient
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11/24/2014
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|
6:40 PM
|
FDA MedWatch RSS Feed
|
Sildenafil may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels.
Full Article
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Bee Thin: Public Notification - Undeclared Drug Ingredient
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11/24/2014
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|
6:40 PM
|
FDA MedWatch RSS Feed
|
Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.
Full Article
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Bee Slim: Public Notification - Undeclared Drug Ingredient
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11/24/2014
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|
6:30 PM
|
FDA MedWatch RSS Feed
|
Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.
Full Article
|
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Gabapentin Capsules, USP 300 mg, by Aurobindo Pharma USA: Recall - Complaints of Empty Capsules
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11/24/2014
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|
4:47 PM
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FDA MedWatch RSS Feed
|
Risk of missed dose(s) resulting in no effect, short term reduction in efficacy, short term withdrawal effect, or status epilepticus (long period seizures) that could be life-threatening.
Full Article
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Highly Concentrated Potassium Chloride Injection, 10 mEq per 100 mL by Baxter: Recall - Mislabeled Overpouch
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11/21/2014
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|
6:30 PM
|
FDA MedWatch RSS Feed
|
Administration of a dose lower than intended, especially in patients prone to severe electrolyte imbalance, may lead to serious, life-threatening adverse health consequences.
Full Article
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Forever Beautiful Bee Pollen by REFA Enterprises: Recall - Undeclared Drug Ingredients
|
11/20/2014
|
|
8:30 PM
|
FDA MedWatch RSS Feed
|
Risk for those with a history of coronary artery disease, congestive heart failure, arrhymias or stroke
Full Article
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Respironics California, Esprit V1000 and V200 Ventilators: Class I Recall - Power Failure May Occur
|
11/19/2014
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|
5:00 AM
|
FDA MedWatch RSS Feed
|
Failure of power supply may cause ventilator to shut off, resulting in too much carbon dioxide or not enough oxygen in patient?s blood, or death.
Full Article
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ABC Dophilus Powder by Solgar, Inc: Recall - Risk of Infection
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11/17/2014
|
|
3:40 PM
|
FDA MedWatch RSS Feed
|
The product was found to contain Rhizopus oryzae, which may cause health problems to consumers, particularly premature infants/infants, children, and those with weakened immune systems.
Full Article
|
|
Long-term Antiplatelet Therapy: Safety Announcement - Preliminary Trial Data Shows Benefits But a Higher Risk of Non-Cardiovascular Death
|
11/16/2014
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|
10:00 PM
|
FDA MedWatch RSS Feed
|
FDA believes the benefits of clopidogrel (Plavix) and prasugrel (Effient) therapy continue to outweigh their potential risks when used for approved uses.
Full Article
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Gel-E Donut and Squishon 2 Products by Children?s Medical Ventures: Recall - Potential Mold Contamination
|
11/15/2014
|
|
3:05 AM
|
FDA MedWatch RSS Feed
|
There is the possibility of fungal infection should patients come in contact with the mold.
Full Article
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Mayhem: Public Notification - Undeclared Drug Ingredients
|
11/14/2014
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|
2:50 PM
|
FDA MedWatch RSS Feed
|
Risk of impaired ability to fight infections, high blood sugar levels, muscle injuries, and psychiatric problems.
Full Article
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Nellcor Puritan Bennett, 980 Ventilator System: Class I Recall - Software Issue May Stop Ventilator
|
11/7/2014
|
|
5:15 PM
|
FDA MedWatch RSS Feed
|
Ventilator may stop working after the air and oxygen gas supply lines are disconnected and then reconnected. This can lead to serious health problems or death.
Full Article
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GemStar Power Supply, 3VDC for GemStar Infusion Pumps by Hospira: Class I Recall - Power Supply May Not Deliver Enough Electricity
|
11/5/2014
|
|
8:15 PM
|
FDA MedWatch RSS Feed
|
Use of recalled devices may cause serious health risks, including delay in therapy, delivery of too much fluid, too high or too low blood pressure, slow or fast heart rhythm/beat, shock, trauma, 1st or 2nd degree burns, smoke inhalation, problems breathing, stroke, and death.
Full Article
|
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V26 Slimming Coffee: Public Notification - Undeclared Drug Ingredient
|
11/5/2014
|
|
1:00 PM
|
FDA MedWatch RSS Feed
|
Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.
Full Article
|
|
Bartlett Milling Company Issues Recall of Horse Food
|
11/3/2014
|
|
1:40 PM
|
FDA Pet Health RSS Feed
|
Bartlett Milling Company has initiated a limited recall of certain horse feeds due to potential Rumensin contamination. The products were distributed to customers and retailers in North Carolina, South Carolina, Tennessee and Virginia.
Full Article
|
|
10 Percent Neutral Buffered Formalin by Richard-Allan Scientific: Class I Recall - May Contain Incorrect Concentration of Formalin
|
10/31/2014
|
|
8:25 PM
|
FDA MedWatch RSS Feed
|
Use of this defective Formalin may prevent or delay diagnoses and treatment decisions.
Full Article
|
|
Ginseng Kianpi Pil: Public Notification - Undeclared Drug Ingredients
|
10/31/2014
|
|
12:40 PM
|
FDA MedWatch RSS Feed
|
Risk of impaired ability to fight infections, high blood sugar levels, muscle injuries and psychiatric problems. Undeclared drug ingredients may also cause serious side effects when combined with other medications.
Full Article
|
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Shur-Green Farms Issues Voluntary Nationwide Recall of Lascadoil/Soyoil Due to Possible Lasalocid Contamination
|
10/27/2014
|
|
6:50 PM
|
FDA Pet Health RSS Feed
|
Shur-Green Farms LLC(Ansonia, OH) has voluntarily recalled loads of Soyoil containing Lascadoil, industrial processing waste oil, which was intended for non-food product or bio-fuels but may have been used as a feed ingredient. This voluntary recall is the result of death in turkeys.
Full Article
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Baby Wipes by Nutek Disposables, Inc.: Recall - May Contain Bacteria
|
10/27/2014
|
|
3:20 PM
|
FDA MedWatch RSS Feed
|
Those with weakened immune system or chronic lung disease may be more susceptible to infections with B. cepacia.
Full Article
|
|
Intravia Containers by Baxter: Recall - Particulate Matter
|
10/25/2014
|
|
4:00 AM
|
FDA MedWatch RSS Feed
|
Intravenous administration of a solution containing sterile particulate matter may lead to adverse health consequences. Posted 10/25/2014
Full Article
|
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Assured Brand Naproxen Sodium Tablets by Contract Packaging Resources, Inc.: Recall - Packaging Mix-Up
|
10/22/2014
|
|
12:30 PM
|
FDA MedWatch RSS Feed
|
Risk of allergic reactions, from mild irritation or hives to serious reactions such as anaphylaxis that may be life-threatening.
Full Article
|
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Saba Shark Cartilage Complex, 60 Capsule Bottles: Recall - Possible Salmonella Contamination
|
10/20/2014
|
|
9:00 PM
|
FDA MedWatch RSS Feed
|
Salmonella can cause serious and sometimes fatal infections in young children frail or elderly people, and others with weakened immune systems. Posted 10/20/2014
Full Article
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|
September 2014 - Drug Safety Labeling Changes
|
10/16/2014
|
|
1:00 PM
|
FDA MedWatch RSS Feed
|
September 2014 Drug Safety Labeling Changes includes 55 products with revisions to Prescribing Information.
Full Article
|
|
LifeCare Flexible Intravenous Solutions by Hospira, Inc.: Recall - Potential for Leakage
|
10/15/2014
|
|
1:30 PM
|
FDA MedWatch RSS Feed
|
A puncture in the primary container may be difficult to detect and lead to contamination, compromised sterility, and other adverse events.
Full Article
|
|
Sit and Slim II: Public Notification - Hidden Drug Ingredients
|
10/10/2014
|
|
5:20 PM
|
FDA MedWatch RSS Feed
|
FDA analysis found these products to contain undeclared Sibutramine, which may increase blood pressure and/or pulse rate, and may also interact in life-threatening ways with other medications.
Full Article
|
|
ICU Medical ConMed Stat2 Flow Controller: Class 1 Recall - Delivers Higher Flow Rate than Intended
|
10/10/2014
|
|
1:00 PM
|
FDA MedWatch RSS Feed
|
Use of the affected product may cause serious adverse health consequences, including death.
Full Article
|
|
CareFusion EnVe and ReVel Ventilators: Class 1 Recall - Power Connection Failure
|
10/10/2014
|
|
1:00 PM
|
FDA MedWatch RSS Feed
|
Ventilator shut-off from power failures may lead to serious patient injury or death.
Full Article
|
|
Oregon Compounding Centers, Inc. Unexpired Sterile Products: Recall - Lack of Sterility Assurance
|
10/10/2014
|
|
12:35 PM
|
FDA MedWatch RSS Feed
|
Patients in Oregon and Washington may be at risk of serious infections which may be life threatening.
Full Article
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Vancomycin Hydrochloride for Injection USP, Equivalent to 1 Gram Vancomycin (Sterile Powder) by Hospira, Inc.: Recall - Uncontrolled Storage During Transit
|
10/8/2014
|
|
7:00 PM
|
FDA MedWatch RSS Feed
|
One lot may have experienced temperature excursions during shipment.
Full Article
|
|
SAM Junctional Tourniquet Accessory (Axilla) Strap - SAM Medical Products: Recall - Potential Clip Failure
|
10/8/2014
|
|
12:00 PM
|
FDA MedWatch RSS Feed
|
Product failure could cause a potential delay in controlling axilla hemorrhage.
Full Article
|
|
Hudson RCI Pediatric Anesthesia Breathing Circuits by Teleflex Medical: Class I Recall - Circuit Ends May Crack or Break
|
10/7/2014
|
|
7:10 PM
|
FDA MedWatch RSS Feed
|
Defect could cause serious health risks, including delayed patient treatment, breathing difficulties, or death if not replaced immediately.
Full Article
|
|
Ketorolac Tromethamine Injection, USP, 30mg/ml by Sagent Pharmaceuticals: Recall - Incorrect Labeling
|
10/6/2014
|
|
2:15 PM
|
FDA MedWatch RSS Feed
|
The labeled expiration date is longer than the known stability of the product.
Full Article
|
|
Bo Ying Compound by Eu Yan Sang (Hong Kong) Ltd: FDA/CDER Statement - Risk of Lead Poisoning
|
9/27/2014
|
|
12:00 AM
|
FDA MedWatch RSS Feed
|
Exposure to lead can cause serious damage to the central nervous system, the kidneys, and the immune system.
Full Article
|
|
Bravo Recalls Select Chicken and Turkey Pet Foods Because of Possible Salmonella Health Risk
|
9/26/2014
|
|
11:29 PM
|
FDA Pet Health RSS Feed
|
(Manchester, CT) Bravo of Manchester, CT is recalling select lots of Bravo Turkey and Chicken pet foods for dogs and cats because they have the potential to be contaminated with Salmonella. Salmonella can affect animals eating the products and there is risk to humans from handling contaminated pet products, especially if they have not thoroughly washed their hands after having contact with the products or any surfaces exposed to these products.
Full Article
|
|
Xolair (omalizumab): Drug Safety Communication - Slightly Elevated Risk of Cardiovascular and Cerebrovascular Serious Adverse Events
|
9/26/2014
|
|
6:00 PM
|
FDA MedWatch RSS Feed
|
FDA approves label changes after review of a five year safety study.
Full Article
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|
Potassium Chloride Injection (Baxter): Recall - Shipping Carton Mislabeling
|
9/17/2014
|
|
7:00 PM
|
FDA MedWatch RSS Feed
|
Potential risk of medication error or delay in therapy for patients that require high concentration potassium chloride.
Full Article
|
|
Heparin Sodium, 1,000 USP Heparin Units/500 mL (2 USP Heparin Units/mL), In 0.9 percent Sodium Chloride Injection, 500 mL by Hospira: Recall - Particulate Matter
|
9/12/2014
|
|
1:00 PM
|
FDA MedWatch RSS Feed
|
Risk of injected particulate material which may result in local inflammation, phlebitis, and/or low-level allergic response.
Full Article
|
|
Martin Avenue Pharmacy, Inc. Compounded Sterile Preparations: Recall - Lack of Assurance of Sterility
|
9/2/2014
|
|
7:00 PM
|
FDA MedWatch RSS Feed
|
Compromised sterility of a compounded preparation may lead to risk for infection.
Full Article
|
|
Dermatend Original and Dermatend Ultra: Recall - Safety Concerns
|
9/2/2014
|
|
3:20 PM
|
FDA MedWatch RSS Feed
|
Using these Dermatend products instead of seeking medical attention could result in delayed diagnosis of conditions such as cancer.
Full Article
|
|
PEDIGREE Adult Complete Nutrition Limited Recall Due to Metal Fragments (Expanded)
|
9/1/2014
|
|
7:47 PM
|
FDA Pet Health RSS Feed
|
At PEDIGREE, we care about all dogs and their safety and well-being is extremely important to us, and to our mission - to make a Better World for Pets. For that reason, we have announced the extension of a previous voluntary recall of PEDIGREE Adult Complete Nutrition dry dog food products due to the possible presence of a foreign material.
Full Article
|
|
DePuy Synthes Craniomaxillofacial Distraction System: Class I Recall - May Reverse Directions After Surgery
|
8/28/2014
|
|
11:10 AM
|
FDA MedWatch RSS Feed
|
Infants at highest risk for injury. Sudden obstruction of trachea could lead to respiratory arrest/death. In all patient populations, failure may result in need for surgical intervention to replace failed device.
Full Article
|
|
Mars Petcare US Announces Voluntary Recall of 22 Bags of PEDIGREE? Brand Adult Complete Nutrition for Dogs Sold at Dollar General in Mississippi, Arkansas, Tennessee and Louisiana
|
8/27/2014
|
|
7:02 PM
|
FDA Pet Health RSS Feed
|
Today, Mars Petcare US announced a voluntary recall of 22 bags of PEDIGREE? Adult Complete Nutrition dry dog food products due to the possible presence of a foreign material. The bags were produced in one manufacturing facility, and shipped to one retail customer
Full Article
|
|
Sterile Convenience Surgical Packs by Customed, Inc.: Recall - Potential Loss of Sterility
|
8/26/2014
|
|
1:10 PM
|
FDA MedWatch RSS Feed
|
Potential adhesion defect which may lead to infection.
Full Article
|
|
Children’s Medical Ventures Gel-E Donut and Squishon 2: Class 1 Recall - Possibility of Mold
|
8/22/2014
|
|
4:00 PM
|
FDA MedWatch RSS Feed
|
Cladosporium and Penicillium Fungi which may cause difficulty in breathing, allergic reactions and serious health consequences, including death.
Full Article
|
|
CloverSnare 4-Loop Vascular Retrieval Snare by Cook Medical: Recall - Risk of Loop to Separate From Shaft
|
8/20/2014
|
|
7:50 PM
|
FDA MedWatch RSS Feed
|
Use of affected product may result in loss of device function, potential for embolization of snare fragments, and the potential need for intervention to retrieve the separated snare.
Full Article
|
|
Diamondback 360 Peripheral Orbital Atherectomy System by Cardiovascular Systems: Class I Recall - Sheath May Fracture During Use
|
8/19/2014
|
|
5:50 PM
|
FDA MedWatch RSS Feed
|
Fragments of the sheath could possibly block blood vessels.
Full Article
|
|
Dianeal Low Calcium (2.5mEq/L) Peritoneal Dialysis Solution with 2.5 Percent Dextrose 5000mL (Ambu-Flex II): Recall - Presence of Particulate Matter
|
8/15/2014
|
|
8:00 PM
|
FDA MedWatch RSS Feed
|
Particulate matter could potentially serve as a focal point for infection should any pre-existing peritonitis exist, and may lead to a fatal outcome.
Full Article
|
|
IPM Wound Gel by Edwards Pharmaceuticals: Class I Recall - Microbial Contamination
|
8/12/2014
|
|
10:00 PM
|
FDA MedWatch RSS Feed
|
Use of the affected product may cause serious adverse health consequences, including sepsis, limb loss, and death.
Full Article
|
|
Arize: Public Notification - Undeclared Drug Ingredient
|
8/11/2014
|
|
6:40 PM
|
FDA MedWatch RSS Feed
|
Undeclared sulfoaildenafil may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels.
Full Article
|
|
Herbal Vigor Quick Fix: Public Notification - Undeclared Drug Ingredient
|
8/11/2014
|
|
6:30 PM
|
FDA MedWatch RSS Feed
|
Undeclared tadalafil may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels.
Full Article
|
|
CUBICIN (daptomycin for injection) 500 mg in 10 mL Single Use Vials: Recall - Foreign Particulate Matter
|
8/9/2014
|
|
4:00 AM
|
FDA MedWatch RSS Feed
|
Administration of particulate matter poses a potential safety risk to patients such as a thromboembolism or a life-threatening pulmonary embolism.
Full Article
|
|
White and Blue Lion Tattoo Kits: Recall - Bacterial Contamination of Needles and Ink Bottles
|
8/8/2014
|
|
7:20 PM
|
FDA MedWatch RSS Feed
|
Use of these products may cause bacterial infection and can lead to sepsis, a potentially life-threatening complication of an infection.
Full Article
|
|
RegenESlim Appetite Control Capsules: Recall - Presence Of DMAA
|
8/8/2014
|
|
2:00 AM
|
FDA MedWatch RSS Feed
|
DMAA can narrow blood vessels and arteries, which can cause a rise in blood pressure or other cardiovascular problems such as shortness of breath, arrhythmias, tightening in the chest, and heart attack.
Full Article
|
|
Cubicin (daptomycin for injection) 500 mg in 10 mL Single Use Vials: Recall - Presence Of Particulate Matter
|
8/8/2014
|
|
1:45 AM
|
FDA MedWatch RSS Feed
|
The administration of a glass particulate poses a potential safety risk to patients such as a thromboembolism or a life-threatening pulmonary emboli.
Full Article
|
|
Expression Injectable by Enhancement Medical: FDA Safety Communication - Adverse Events Associated with Unapproved Use As a Dermal Filler
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8/5/2014
|
|
7:45 PM
|
FDA MedWatch RSS Feed
|
Events have included swelling, tenderness, firmness, lumps, bumps, bruising, pain, redness, discoloration, itching, and the development of hard nodules.
Full Article
|
|
Lidocaine HCI Injection, USP, 2 percent, by Hospira: Recall - Visible Particulates
|
7/30/2014
|
|
12:55 PM
|
FDA MedWatch RSS Feed
|
Injected particulate could result in delay in therapy, local inflammation, mechanical disruption of tissue or immune response to the particulate.
Full Article
|
|
Ibuprofen and Oxcarbazepine Tablets by American Health Packaging: Recall - Mislabeled Packaging
|
7/21/2014
|
|
6:30 PM
|
FDA MedWatch RSS Feed
|
Failure to receive the proper dose of oxcarbazepine could increase the chances of patients having a seizure and inadvertent consumption of ibuprofen may cause adverse reactions.
Full Article
|
|
Sterile Drug Products by Downing Labs (aka NuVision Pharmacy): Drug Alert - Lack of Sterility Assurance
|
7/19/2014
|
|
4:00 AM
|
FDA MedWatch RSS Feed
|
Administration of a non-sterile drug product intended to be sterile may result in serious and potentially life-threatening infections or death
Full Article
|
|
Baxter IV Sodium Chloride and Potassium Chloride Solutions: Recall - Particulate Matter
|
7/18/2014
|
|
3:30 PM
|
FDA MedWatch RSS Feed
|
If infused, the presence of particulate foreign matter may elicit inflammatory and allergic responses, both chronic and acute, and may be life threatening.
Full Article
|
|
Sterile Drug Products by Unique Pharmaceuticals Ltd.: Recall - Lack of Sterility Assurance
|
7/12/2014
|
|
12:00 AM
|
FDA MedWatch RSS Feed
|
Administration of a non-sterile drug product intended to be sterile may result in serious and potentially life-threatening infections or death.
Full Article
|
|
Hospira Lactated Ringer's And 5% Dextrose Injection, 1000 ML, Flexible Containers: Recall (One Lot) - Mold Contamination
|
7/11/2014
|
|
3:15 PM
|
FDA MedWatch RSS Feed
|
Voluntary Nationwide Recall Of One Lot. Intravenous administration of a non-sterile product can result in infections that may be life-threatening, and may result in prolonged hospitalization or organ failure.
Full Article
|
|
Weight Loss Products: Public Notification - Undeclared Drug Ingredients
|
7/9/2014
|
|
5:00 PM
|
FDA MedWatch RSS Feed
|
May present significant risk for patients with history of CAD, CHF, arrhythmias, or stroke.
May interact, in life-threatening ways, with other medications.
Full Article
|
|
Langston V2 Dual Lumen Catheters (Models 5540 and 5550) by Vascular Solutions: Class I Recall - Inner Catheter May Separate During Use and Cause Injury
|
7/7/2014
|
|
5:20 PM
|
FDA MedWatch RSS Feed
|
The use of affected product may cause serious adverse health consequences, including death.
Full Article
|
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Medtronic Duet External Drainage and Monitoring System, Medtronic Neurosurgery: Class 1 Recall - Tubing May Disconnect and Lead to Injury
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7/2/2014
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|
7:20 PM
|
FDA MedWatch RSS Feed
|
Device failure may result in air within skull, infection, and over/under drainage of CSF that may contribute to serious adverse health consequences, including death.
Full Article
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Cargill Conducts Voluntary Recall of Select Nutrena? NatureWise? Meatbird Feed Due to Possible Animal Health Risk
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7/2/2014
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|
6:48 PM
|
FDA Pet Health RSS Feed
|
Minneapolis, Minn., - 1 July 2014 ? Cargill?s animal nutrition business today announced a voluntary recall of its Nutrena NatureWise meatbird feed due to excess levels of sodium. Sodium is an essential nutrient for poultry.
Full Article
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Coumadin (warfarin sodium) for Injection by Bristol-Myers Squibb: Recall - Particulate Matter
|
7/1/2014
|
|
5:10 PM
|
FDA MedWatch RSS Feed
|
Injected particulate metallic and non-metallic cellulose material can cause serious and potentially fatal adverse reactions such as embolization.
Full Article
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Medical Supply Liquidators Injectable Vitamin Products With a "Sunshine Labs" Label: Warning - Products Not FDA Approved
|
6/30/2014
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|
6:30 PM
|
FDA MedWatch RSS Feed
|
All lots of non-expired products being recalled.
Full Article
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Lidocaine Viscous: Drug Safety Communication - Boxed Warning Required - Should Not Be Used to Treat Teething Pain
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6/26/2014
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2:00 PM
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FDA MedWatch RSS Feed
|
Too much viscous lidocaine given to infants and young children can result in seizures, severe brain injury, and problems with the heart.
Full Article
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Over-The-Counter Topical Acne Products: Drug Safety Communication - Rare But Serious Hypersensitivity Reactions
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6/25/2014
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5:00 PM
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FDA MedWatch RSS Feed
|
Reactions may include throat tightness; difficulty breathing; feeling faint; or swelling of the eyes, face, lips, or tongue.
Full Article
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Olmesartan: Drug Safety Communication - FDA Review Finds Cardiovascular Risks for Diabetics Not Conclusive
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6/24/2014
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10:10 PM
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FDA MedWatch RSS Feed
|
Recommendations for use remain the same; label updates required.
Full Article
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Red Yeast Rice by Doctor’s Best: Recall - Undeclared Lovastatin
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6/24/2014
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|
9:20 PM
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FDA MedWatch RSS Feed
|
Use could result in serious muscle injury, particularly if taking with prescription “statins”; patients with pre-existing liver disease may be at an increased risk for liver injury.
Full Article
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Big Sky Diagnostic Imaging, LLC in Butte, Montana: FDA Safety Communication - Mammography Problems
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6/23/2014
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5:15 PM
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FDA MedWatch RSS Feed
|
Patients who had a mammogram performed at Big Sky Diagnostic Imaging should speak to their health care providers about whether their mammograms need to be repeated.
Full Article
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Testosterone Products: FDA/CDER Statement - Risk of Venous Blood Clots
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6/20/2014
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8:47 PM
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FDA MedWatch RSS Feed
|
Warning about venous thromboembolism, including deep vein thrombosis and pulmonary embolism.
Full Article
|
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ConvaTec, Inc., Flexi-Seal CONTROL Fecal Management System Kit: Class I Recall - Not Cleared for Marketing
|
6/20/2014
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|
8:36 PM
|
FDA MedWatch RSS Feed
|
Reports of 12 serious injuries and one death.
Full Article
|
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Docetaxel: Drug Safety Communication - May Cause Symptoms of Alcohol Intoxication
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6/20/2014
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|
4:51 PM
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FDA MedWatch RSS Feed
|
Docetaxel contains alcohol, which affects the central nervous system.
Full Article
|
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HydroFinity Hydrophilic Guidewires by NDC/Covidien: Recall - Outer Jacket Damage
|
6/20/2014
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|
11:10 AM
|
FDA MedWatch RSS Feed
|
Damage to the jacket can result in embolization of polymer, potentially leading to vessel occlusion or damage.
Full Article
|
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Weight Loss Products: Immediate Public Notification: Undeclared Drug Ingredients
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6/19/2014
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|
6:10 PM
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FDA MedWatch RSS Feed
|
Products may substantially increase blood pressure and/or pulse rate in some patients.
Full Article
|
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Marcaine (Bupivacaine HCI Injection, USP), 0.5 percent, 30 ML, Single-Dose, Preservative-Free Vial: Recall - Visible Particulates
|
6/18/2014
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|
3:50 PM
|
FDA MedWatch RSS Feed
|
Injected particulate could result in blocked administration of the drug to the patient, causing a delay in therapy.
Full Article
|
|
May 2014 - Drug Safety Labeling Changes
|
6/13/2014
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|
7:03 PM
|
FDA MedWatch RSS Feed
|
Safety Labeling Changes includes 37 products with revisions to Prescribing Information. Posted 06/13/2014.
Full Article
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Captomer and Captomer-250 by Thorne Research: FDA Warning - Potential Health Risks
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6/13/2014
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|
2:15 PM
|
FDA MedWatch RSS Feed
|
FDA advises consumers to avoid all products offered over-the-counter (OTC) for chelation or detoxification.
Full Article
|
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Smiths Medical Portex Low Dead Space Connector with Sideport, 3.5mm: Class I Recall- One Lot Mislabeled
|
6/13/2014
|
|
1:20 PM
|
FDA MedWatch RSS Feed
|
One lot of 3.0mm sized connectors were placed in packages labeled as 3.5mm.
Full Article
|
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Advocate Redi-Code+ Blood Glucose Test Strips by Diabetic Supply of Suncoast: Recall- Labeling Error
|
6/11/2014
|
|
2:30 PM
|
FDA MedWatch RSS Feed
|
Delayed or inappropriate treatment of hyperglycemic or hypoglycemic states due to missed/delayed detection could
lead to serious health consequences, including death.
Full Article
|
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La Jiao Shou Shen: Public Notification - Undeclared Drug Ingredient
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6/11/2014
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|
2:00 PM
|
FDA MedWatch RSS Feed
|
Cancer-causing risk in addition to increased blood pressure and/or pulse rate.
Full Article
|
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PGG/HSC Feed Company LLC Issues Voluntary Recall of Champion Lamb Texturized Feed B30, Lot-88022114M908840
|
6/5/2014
|
|
5:10 PM
|
FDA Pet Health RSS Feed
|
HERMISTON, ORE. -- PGG/HSC Feed Company, LLC, announced today it has implemented a voluntary recall of 50-pound packages of its Champion Lamb Texturized B30 product due to higher than allowable copper levels. The product was manufactured in February 2014 and carries the UPC code UPC-748252483805 located in the bottom left corner of a white label attached to a Payback bag with a photo of a lamb.
Full Article
|
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Male Sexual Enhancement Products: Immediate Public Notification: Undeclared Drug Ingredients
|
6/3/2014
|
|
7:00 PM
|
FDA MedWatch RSS Feed
|
Risk of interaction with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels.
Full Article
|
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Hill?s Pet Nutrition, Inc. Voluntarily Recalls 62 Bags of ?Science Diet? Adult Small & Toy Breed?? Dry Dog Food in California, Hawaii and Nevada Because of Potential Health Risk
|
6/3/2014
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|
2:22 PM
|
FDA Pet Health RSS Feed
|
Hill?s Pet Nutrition, Inc. of Topeka, KS is voluntarily recalling 62 bags of Science Diet? Adult Small & Toy Breed? dry dog food as they have the potential to be contaminated with Salmonella. The suspect product, part of a single production run, was distributed to 17 veterinary clinic and pet store customers in California, Hawaii and Nevada between April 24 and May 13, 2014.
Full Article
|
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Soliris (eculizumab) Concentrated Solution for IV Infusion by Alexion: Recall - Visible Particulates
|
6/2/2014
|
|
6:25 PM
|
FDA MedWatch RSS Feed
|
Particulates could cause blockage of blood flow, which could be life-threatening.
Full Article
|
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Pet Center, Inc. Voluntary Recall of 3 oz bag of Lamb Crunchy’s Because of Possible Health Risk
|
5/28/2014
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|
6:37 PM
|
FDA Pet Health RSS Feed
|
Pet Center, Inc of Los Angeles, CA. is voluntarily recalling its 3 oz bag of Lamb Crunchy’s dog treats (LAM-003) (UPC# 727348200038) with date code 122015 product of USA, because it has the potential to be contaminated with Salmonella.
Full Article
|
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Advanced Sterilization Products Sterrad Cyclesure 24 Biological Indicator: FDA Safety Communication - Product Shortage
|
5/23/2014
|
|
7:50 PM
|
FDA MedWatch RSS Feed
|
Hospitals should prioritize use of existing supplies based on patients with the most critical need until supplies are able to meet demand.
Full Article
|
|
Fisher and Paykel Healthcare, Ltd., Infant Nasal CPAP Prongs: Class I Recall - Prongs May Detach from Nasal Tubing and Interrupt Therapy
|
5/23/2014
|
|
3:05 PM
|
FDA MedWatch RSS Feed
|
Device malfunction may lead to low blood oxygen (hypoxemia), and a risk of choking and airway obstruction.
Full Article
|
|
NaturaLyte Liquid Bicarbonate Concentrate: Recall - Potential Health Risk
|
5/22/2014
|
|
7:10 PM
|
FDA MedWatch RSS Feed
|
Bacterial contamination of the dialysate may lead to bacteremia or systemic infection.
Full Article
|
|
Baxter ABACUS TPN Calculation Software: Class I Recall - Software Errors May Cause Toxic/Overdose Symptoms
|
5/22/2014
|
|
5:30 PM
|
FDA MedWatch RSS Feed
|
A fatal outcome is possible, especially with the high risk population.
Full Article
|
|
Alaris Pump Module (Model 8100), Version 9.1.18 Software by CareFusion 303, Inc: Class I Recall - May Not Properly Delay an Infusion
|
5/21/2014
|
|
1:40 PM
|
FDA MedWatch RSS Feed
|
"Delay Until" Option or "Multidose" feature software failure may result in unintented infusion start time.
Full Article
|
|
Ventlab Resuscitator Bags: Recall - Possible Health Risk
|
5/16/2014
|
|
7:30 PM
|
FDA MedWatch RSS Feed
|
May result in delay of treatment, life threatening health consequences that include hypoxia and hypoventilation.
Full Article
|
|
MV5 Days: Public Notification - Undeclared Drug Ingredient
|
5/16/2014
|
|
6:50 PM
|
FDA MedWatch RSS Feed
|
May interact with nitrates found in some prescription drugs, and may lower blood pressure to dangerous levels.
Full Article
|
|
Asset Bold: Public Notification - Undeclared Drug Ingredient
|
5/16/2014
|
|
6:40 PM
|
FDA MedWatch RSS Feed
|
Risk of increased blood pressure and/or pulse rate.
Full Article
|
|
April 2014 - Drug Safety Labeling Changes
|
5/16/2014
|
|
2:00 PM
|
FDA MedWatch RSS Feed
|
Drug Safety Labeling Changes, April 2014
Full Article
|
|
Labetalol Hydrochloride Injection 100 MG/20 ML (5MG/ML), 20 ML, Multidose Vial by Hospira: Recall - Visible Particulates
|
5/16/2014
|
|
4:00 AM
|
FDA MedWatch RSS Feed
|
Risk of injection site reactions and local irritation in the blood vessels, tissues and organs or delay in therapy.
Full Article
|
|
Eszopiclone Containing Sleep Aids: Drug Safety Communication - Can Cause Next-Day Impairment
|
5/15/2014
|
|
6:50 PM
|
FDA MedWatch RSS Feed
|
FDA recommends a decreased starting dose for both women and men.
Full Article
|
|
Dobutamine Injection (250mg/20mL)/Hospira: Recall - Visible Particulates
|
5/15/2014
|
|
6:35 PM
|
FDA MedWatch RSS Feed
|
Injected particulate matter may result in local inflammation, phlebitis, and/or low level allergic response.
Full Article
|
|
Bravo® Issues Nationwide Recall of Pet Food for Dogs and Cats
|
5/15/2014
|
|
12:13 AM
|
FDA Pet Health RSS Feed
|
Manchester, CT ? Bravo is recalling select lots and product(s) of Bravo Pet Food because they have the potential to be contaminated with Listeria monocytogenes.
Listeria monocytogenes is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.
Full Article
|
|
Pradaxa (dabigatran): Drug Safety Communication - Lower Risk for Stroke and Death, but Higher Risk for GI Bleeding Compared to Warfarin
|
5/13/2014
|
|
6:00 PM
|
FDA MedWatch RSS Feed
|
Study finds lower risk of clot-related strokes, bleeding in brain, and death for Pradaxia versus warfarin, but increased risk of major GI bleeding.
Full Article
|
|
Datascope Corp/MAQUET, Certain Intra-Aortic Balloon Pumps: Recall - Potential Mechanical Failure of Power Supply Fan Assembly
|
5/12/2014
|
|
5:20 PM
|
FDA MedWatch RSS Feed
|
Failure could result in the balloon pump shutting down without warning, which could result in worsened heart failure, decreased blood flow to the heart, and/or decreased blood flow to the body and brain.
Full Article
|
|
Asset Bee Pollen: Public Notification - Undeclared Drug Ingredient
|
5/12/2014
|
|
1:45 PM
|
FDA MedWatch RSS Feed
|
Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients.
Full Article
|
|
Alere INRatio2 PT/INR Professional Test Strips: Recall - Higher INR when Performed by Central Laboratory
|
5/7/2014
|
|
2:30 PM
|
FDA MedWatch RSS Feed
|
Therapeutic or near therapeutic INR with the test strips but a significantly higher INR when performed by a central laboratory.
Full Article
|
|
African Black Ant, Black Ant, and Mojo Risen by Eugene Oregon, Inc: Recall - Undeclared Drug Ingredient
|
5/7/2014
|
|
1:00 AM
|
FDA MedWatch RSS Feed
|
may contain undeclared amounts of sildenafil and tadalafil.
Full Article
|
|
Slim Trim U: Public Notification - Undeclared Drug Ingredient
|
5/6/2014
|
|
1:30 PM
|
FDA MedWatch RSS Feed
|
Risk of increased blood pressure and/or pulse rate.
Full Article
|
|
Natural Body Solution: Public Notification - Undeclared Drug Ingredient
|
5/6/2014
|
|
12:45 PM
|
FDA MedWatch RSS Feed
|
Risk of increased blood pressure and/or pulse rate.
Full Article
|
|
Abbott Acclaim and Hospira Acclaim Encore Infusion Pumps by Hospira, Inc: Class I Recall - Broken Door Assemblies
|
5/2/2014
|
|
10:00 PM
|
FDA MedWatch RSS Feed
|
May Result in Over-Infusion or Delay of Therapy.
Full Article
|
|
Gemstar Docking Station by Hospira, Inc: Class I Recall - Potential for Error or Failure to Power Up
|
5/2/2014
|
|
9:20 PM
|
FDA MedWatch RSS Feed
|
A delay or interruption in therapy has a worst case potential to result in significant injury or death.
Full Article
|
|
Sigma Spectrum Infusion Pumps with Master Drug Library by Baxter Healthcare: Class I Recall - System Error May Interrupt or Delay Therapy
|
5/2/2014
|
|
4:30 PM
|
FDA MedWatch RSS Feed
|
Pump may stop the infusion, requiring a clinician to reset the alarm, reprogram the pump, and confirm the infusion is running properly.
Full Article
|
|
Flawless Beauty and Skin Products: Recall - Unapproved Drugs
|
4/30/2014
|
|
11:45 AM
|
FDA MedWatch RSS Feed
|
Risks include unknown quality, safety, and efficacy.
Full Article
|
|
GenStrip Blood Glucose Test Strips by Shasta Technologies: FDA Safety Communication - May Report False Results
|
4/29/2014
|
|
5:35 PM
|
FDA MedWatch RSS Feed
|
Recent FDA inspection of manufacturer found extensive violations of federal regulations intended to assure the quality of product.
Full Article
|
|
HeartWare, Inc., Heartware Ventricular Assist System: Class I Recall - Locking Mechanism of Pump Driveline Connector May Fail to Engage
|
4/29/2014
|
|
5:10 PM
|
FDA MedWatch RSS Feed
|
Failure could result in the pump stopping and lead to serious adverse health consequences, including death.
Full Article
|
|
Super Arthgold by Nano Well-being Health: Recall - Undeclared Drug Ingredients
|
4/24/2014
|
|
2:40 PM
|
FDA MedWatch RSS Feed
|
Risk of myocardial infarction, stroke, congestive heart failure, renal toxicity, and bleeding, ulceration, or perforation of the stomach or intestines.
Full Article
|
|
Epidural Corticosteroid Injection: Drug Safety Communication - Risk of Rare But Serious Neurologic Problems
|
4/23/2014
|
|
3:00 PM
|
FDA MedWatch RSS Feed
|
Injection of corticosteroids into the epidural space of the spine may result in loss of vision, stroke, paralysis, and death.
Full Article
|
|
Marcaine (Bupivacaine HCI Injection, USP) 0.25 percent, 10 ml, Single-Dose, Preservative-Free Vial: Recall - Visible Particulates
|
4/22/2014
|
|
9:09 PM
|
FDA MedWatch RSS Feed
|
Injected particulate could result in local inflammation, mechanical disruption of tissue or immune response to the particulate.
Full Article
|
|
Thinogenics Products by Nature’s Universe: Recall - Undeclared Drug Ingredient
|
4/18/2014
|
|
5:40 PM
|
FDA MedWatch RSS Feed
|
Use of undeclared sibutramine can lead to increased risk of seizures, heart attacks, arrhythmia and stroke.
Full Article
|
|
Propofol Injectable Emulsion, USP by Hospira: Recall - Visible Particulates
|
4/18/2014
|
|
3:55 PM
|
FDA MedWatch RSS Feed
|
Injected particulate matter may result in local inflammation, phlebitis, and/or low level allergic response through mechanical disruption of tissue or immune response to the particulate.
Full Article
|
|
S.W.A.G: Public Notification - Undeclared Drug Ingredient
|
4/18/2014
|
|
12:15 PM
|
FDA MedWatch RSS Feed
|
Contains undeclared Sildenafil, which may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels.
Full Article
|
|
CUBICIN (daptomycin for injection) by Cubist Pharmaceuticals: Recall - Presence of Particulate Matter
|
4/18/2014
|
|
4:00 AM
|
FDA MedWatch RSS Feed
|
Potential risk of thromboembolism, pulmonary emboli, phlebitis, mechanical block of the capillaries or arterioles, activation of platelets, subsequent generation of microthrombi, and emboli.
Full Article
|
|
Lidocaine HCI Injection, USP, by Hospira: Recall - Visible Particulates
|
4/18/2014
|
|
4:00 AM
|
FDA MedWatch RSS Feed
|
Risk of local inflammation, and/or mechanical disruption of tissue or immune response to the particulate, and/or a delay in therapy.
Full Article
|
|
Laparoscopic Power Morcellation in Hysterectomy and Myomectomy: FDA Safety Communication - Use Discouraged Due to Increased Risk in Women With Uterine Fibroids
|
4/17/2014
|
|
5:45 PM
|
FDA MedWatch RSS Feed
|
If laparoscopic power morcellation is performed in women with unsuspected uterine sarcoma, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis.
Full Article
|
|
ARKON Anesthesia Delivery System with Version 2.0 Software by Spacelabs Healthcare: Class I Recall - Software Defect May Cause System to Stop Working
|
4/16/2014
|
|
10:00 PM
|
FDA MedWatch RSS Feed
|
Defect may cause serious adverse health consequences, including hypoxemia and death.
Full Article
|
|
Infinity: Public Notification - Undeclared Drug Ingredient
|
4/11/2014
|
|
6:40 PM
|
FDA MedWatch RSS Feed
|
Use may increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.
Full Article
|
|
Lite Fit USA: Public Notification - Undeclared Drug Ingredient
|
4/11/2014
|
|
6:30 PM
|
FDA MedWatch RSS Feed
|
Use may increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.
Full Article
|
|
March 2014 - Drug Safety Labeling Changes
|
4/11/2014
|
|
2:55 PM
|
FDA MedWatch RSS Feed
|
Safety Labeling Changes includes 30 products with revisions to Prescribing Information. Posted 04/11/2014.
Full Article
|
|
Covidien Pipeline Embolization Device and Alligator Retrieval Device: Recall - Coating on Delivery Wire Could Delaminate
|
4/11/2014
|
|
7:10 AM
|
FDA MedWatch RSS Feed
|
Use of affected products could potentially lead to embolic occlusion in the cerebral vasculature, with the risk of stroke and/or death.
Full Article
|
|
The Robert Abady Dog Food Co., LLC Recalls "Abady Highest Quality Maintenance & Growth Formula for Cats" Because of Possible Health Risk
|
4/9/2014
|
|
7:10 PM
|
FDA Pet Health RSS Feed
|
The Robert Abady Dog Food Co., LLC of Poughkeepsie, NY, is recalling its 2 lb, 5 lb & 15 lb boxes of "Abady Highest Quality Maintenance & Growth Formula for Cats" because they have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.
Full Article
|
|
Zi Xiu Tang Bee Pollen Capsules by Guangzhou Zi Xiu Tang Biotechnology Co., Ltd: Warning - Undeclared Drug Ingredients
|
4/8/2014
|
|
12:00 PM
|
FDA MedWatch RSS Feed
|
Risk of increased blood pressure and/or pulse rate.
Full Article
|
|
PS500 Power Supply Unit by Dr?ger: Recall - Early Depletion of Battery Charge
|
4/2/2014
|
|
8:30 PM
|
FDA MedWatch RSS Feed
|
Battery depletion will require manual ventilation until the device is connected to main power.
Full Article
|
|
Revatio (sildenafil): Drug Safety Communication - FDA Clarifies Warning About Pediatric Use for Pulmonary Arterial Hypertension
|
3/31/2014
|
|
5:00 PM
|
FDA MedWatch RSS Feed
|
Health care professionals must consider whether the benefits of treatment with the drug are likely to outweigh its potential risks for each patient.
Full Article
|
|
Nova Products, Inc. Dietary Supplements: Recall - Undeclared Drug Ingredients
|
3/31/2014
|
|
4:40 PM
|
FDA MedWatch RSS Feed
|
Sildenafil and tadalafil can interact with nitrates found in some prescription drugs (such as nitroglycerin), resulting in decreased blood pressure.
Full Article
|
|
Alli (60 mg orlistat capsules) by GlaxoSmithKline: Recall - Product Tampering
|
3/28/2014
|
|
6:07 PM
|
FDA MedWatch RSS Feed
|
Some packages of the product were tampered with and may contain product that is not authentic.
Full Article
|
|
Bella Vi Brand Products by Pure Edge Nutrition: Recall - Undeclared Drug Ingredients
|
3/26/2014
|
|
7:15 PM
|
FDA MedWatch RSS Feed
|
Sibutramine can increase blood pressure and/or pulse rate in some patients and may present a risk for those with a history of coronary artery disease, congestive heart failure, arrhymias or stroke.
Full Article
|
|
New Life Nutritional Center Dietary Supplements: Recall - Undeclared Drug Ingredients
|
3/26/2014
|
|
3:55 PM
|
FDA MedWatch RSS Feed
|
Undeclared sibutramine and phenolphthalein make these products unapproved new drugs for which safety and efficacy have not been established.
Full Article
|
|
Pleo Homeopathic Drug Products by Terra-Medica: Recall - Potential for Undeclared Penicillin
|
3/21/2014
|
|
2:05 AM
|
FDA MedWatch RSS Feed
|
Exposure to penicillin can result in a range of allergic reactions from mild rashes to severe and life-threatening anaphylactic reactions.
Full Article
|
|
February 2014 - Drug Safety Labeling Changes
|
3/19/2014
|
|
6:26 PM
|
FDA MedWatch RSS Feed
|
Drug Safety Labeling Changes, February 2014
Full Article
|
|
Vitaccino Coffee: Public Notification - Undeclared Drug Ingredient
|
3/19/2014
|
|
4:30 PM
|
FDA MedWatch RSS Feed
|
Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients, and may also present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.
Full Article
|
|
Playtex Nurser Deluxe Double Electric Breast Pump: Recall - Potential for Electric Shock
|
3/19/2014
|
|
1:18 PM
|
FDA MedWatch RSS Feed
|
The casing on some AC/DC power adapters may become loose and separate, resulting in a potential for electric shock.
Full Article
|
|
Hospira Hemostat Dual Channel Plum Set: Recall-Risk of over-delivery of blood products
|
3/18/2014
|
|
7:30 PM
|
FDA MedWatch RSS Feed
|
Over-delivery of blood products in the populations at greatest risk may result in injuries that require medical intervention.
Full Article
|
|
Hospira Announces Voluntary Nationwide Recall of Hemoset Blood Set
|
3/18/2014
|
|
7:00 PM
|
FDA Pet Health RSS Feed
|
Hospira, Inc. (NYSE: HSP), announced today a nationwide recall of two lots of Hemoset Dual Channel Plum Sets (list number 11241-03, lot numbers 28005-5H and 34100-5H). Hospira identified that an incorrect set component was supplied and used during the manufacturing process of the impacted product lots.
Full Article
|
|
FreeStyle and FreeStyle Flash Blood Glucose Meter by Abbott: Recall - May Produce Mistakenly Low Blood Glucose Results
|
3/17/2014
|
|
12:00 AM
|
FDA MedWatch RSS Feed
|
Symptoms of high blood sugar include excessive thirst, excessive urination, blurred vision, weakness, nausea, vomiting and abdominal pain.
Full Article
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McKesson Technologies Anesthesia Care: Recall ? Patient Case Data May Not Match Patient Data
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3/15/2014
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1:58 AM
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FDA MedWatch RSS Feed
|
Class 1 recall of computer-based system.
Full Article
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VPRIV (velaglucerase alfa for injection): Recall - Visible Particulate Matter
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3/14/2014
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7:50 PM
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FDA MedWatch RSS Feed
|
Risk of rare but serious adverse events associated with infusion containing particulates.
Full Article
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Reumofan Plus: Recall - Undeclared Drug Ingredient
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3/14/2014
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6:30 PM
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FDA MedWatch RSS Feed
|
UPDATED 03/14/2014. Pain Free by Nature is voluntarily recalling all lots of Reumofan Plus Tablets. Originally posted 06/01/2012.
Full Article
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Merit Medical Systems, Custom Procedural Trays/Kits Containing 1 percent Lidocaine HCl Injection, USP, 10mg/mL: Recall - Particulates Found in Hospira supplied Lidocaine
|
3/14/2014
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1:30 PM
|
FDA MedWatch RSS Feed
|
Presence of oxidized stainless steel particulate may put a patient at risk from strong magnetic field exposure such as MRI, and other adverse events resulting in serious life-threatening complications.
Full Article
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Greatbatch, Inc. Standard Offset Cup Impactors: Recall - Sterilization Recommendation in Instructions Do Not Meet Sterility Assurance Requirements
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3/12/2014
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2:10 PM
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FDA MedWatch RSS Feed
|
Lack of sterility assurance has the potential to result in surgical infection.
Full Article
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Effexor XR 150 Mg Extended-Release Capsules (Pfizer) and Venlafaxine HCl 150 Mg Extended-Release Capsules (Greenstone): Recall - Possible Presence of Tikosyn Capsules
|
3/7/2014
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1:20 PM
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FDA MedWatch RSS Feed
|
The use of Tikosyn by an Effexor XR/Venlafaxine HCl patient could cause serious adverse health consequences that could be fatal.
Full Article
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DIANEAL PD-2 Peritoneal Dialysis Solution with 1.5 Percent Dextrose 6000mL: Recall - Contamination With Mold
|
3/7/2014
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1:20 AM
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FDA MedWatch RSS Feed
|
Administration of a product contaminated with mold could result in life-threatening fungal peritoneal infection or sepsis.
Full Article
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Doribax (doripenem): Drug Safety Communication - Risk When Used to Treat Pneumonia on Ventilated Patients
|
3/7/2014
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1:20 AM
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FDA MedWatch RSS Feed
|
Increased risk of death and lower clinical cure rates compared to use of imipenem and cilastatin.
Full Article
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HeartMate II LVAS Pocket System Controller by Thoratec Corporation: Medical Device Correction - Updated Labeling and Training Materials
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3/5/2014
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3:10 PM
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FDA MedWatch RSS Feed
|
Reports of four deaths and five incidents of loss of consciousness or other symptoms of hypoperfusion, occurring in patients who were converted to the Pocket Controller after being originally trained on an older model.
Full Article
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GE Healthcare Resuscitation Systems: Class I Recall - Oxygen and Air Inlet Fittings Reversed During Assembly
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2/28/2014
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8:20 PM
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FDA MedWatch RSS Feed
|
Recalled products may interfere with oxygen delivery, resulting in inaccurate oxygen regulation in neonates. This may cause death in neonates, particularly those who are critically ill.
Full Article
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ACME Monaco Guidewire .035x150 3MMJ TCFC, Item 88241 by Medline Industries: Class I Recall - Potential for Coating to Flake Off
|
2/25/2014
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|
6:09 PM
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FDA MedWatch RSS Feed
|
Use of this recalled product may result in serious adverse health consequences.
Full Article
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ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port (with and without Preloaded Stylet) by Teleflex Medical ? Class I Recall: Potential Kinking During Patient Use
|
2/24/2014
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7:28 PM
|
FDA MedWatch RSS Feed
|
If a tracheal tube kinks, it can deprive the patient of adequate ventilation causing serious patient injury including hypoxic injury and/or anoxia, and death.
Full Article
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Etomidate Injection/Pfizer-Mylan: Recall - Presence of Particulate Matter and/or Illegible and Missing Lot Number and/or Expiry Date
|
2/20/2014
|
|
8:00 PM
|
FDA MedWatch RSS Feed
|
Intravenous administration of particles may lead to impairment of microcirculation, phlebitis, infection, embolism and subsequent infarction.
Full Article
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Med-Vet International Issues Nationwide Recall of Veterinary 1/2cc U-40 Insulin Syringes Due to Mismarked Syringe Barrels
|
2/20/2014
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|
5:44 PM
|
FDA Pet Health RSS Feed
|
On Feb. 14, 2014 , Med-Vet International initiated a nationwide recall of 140 boxes of 1/2cc U-40 insulin
syringes. The syringes have been found to be labeled with 40 units per 1/2cc syringe and they should be
marked with only 20 units per 1/2cc, which potentially could result in lower than prescribed doses of
insulin.
Full Article
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Trilogy Ventilator Models 100, 200 and 202 by Philips Respironics: Recall - Failure to Deliver Mechanical Breaths
|
2/20/2014
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|
1:00 PM
|
FDA MedWatch RSS Feed
|
Potential ventilator failure and reduced alarm functionality may result in serious adverse health consequences or death.
Full Article
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Acetylcysteine Solution 10 Percent: Recall - Glass Particles in Product
|
2/15/2014
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|
2:45 PM
|
FDA MedWatch RSS Feed
|
Use of an inhaled product with glass particles has potential to cause choking which could be life-threatening. Aerosolization of small glass particles in airways could result in recurrent infections.
Full Article
|
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Reduce Weight Fruta Planta: Recall - Undeclared Drug Ingredient
|
2/14/2014
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|
2:50 PM
|
FDA MedWatch RSS Feed
|
Consumption of this product could include potentially serious gastrointestinal disturbances, irregular heartbeat, and cancer with long-term use.
Full Article
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L-citrulline by Medisca: Alert - Potentially Subpotent Product
|
2/14/2014
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2:00 PM
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FDA MedWatch RSS Feed
|
Subpotent L-citrulline in patients with certain urea cycle defects can lead to high ammonia levels, which is serious and potentially life-threatening.
Full Article
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Saxagliptin (marketed as Onglyza and Kombiglyze XR): Drug Safety Communication - FDA to Review Heart Failure Risk
|
2/11/2014
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|
3:25 PM
|
FDA MedWatch RSS Feed
|
FDA has requested clinical trial data from the manufacturer of saxagliptin to investigate a possible association between use of the type 2 diabetes drug and heart failure.
Full Article
|
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Calcium gluconate 10 percent Injections by Rx Formulations: Recall - Microbial Contamination
|
2/7/2014
|
|
4:40 PM
|
FDA MedWatch RSS Feed
|
FDA testing confirmed the presence of gram-positive rod bacteria in the product, which can cause infection in patients.
Full Article
|
|
Pro-Pet LLC Recalls a Limited Number of Dry Dog and Cat Foods Due to Possible Salmonella Contamination
|
2/6/2014
|
|
1:27 PM
|
FDA Pet Health RSS Feed
|
Pro-Pet LLC, St. Marys, Ohio, has initiated a voluntary recall of a limited number of Dry Dog and Cat Foods for possible Salmonella contamination. A single field test indicated products manufactured during a two day period, on a single production line may have the potential for Salmonella contamination.
Full Article
|
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Testosterone Products: Drug Safety Communication - FDA Investigating Risk of Cardiovascular Events
|
1/31/2014
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|
9:30 PM
|
FDA MedWatch RSS Feed
|
FDA assessing safety issues based on two separate studies that suggested an increased risk of cardiovascular events among groups of men prescribed testosterone therapy.
Full Article
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|
FDA Pet Health RSS feed error
|
1/31/2014
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|
9:24 PM
|
FDA Pet Health RSS Feed
|
Earlier this week, FDA’s Pet Health RSS feed erroneously distributed outdated items. In reviewing information you’ve received through this feed, please reference the corrected information available at http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/PetHealth/rss.xml. Please note the date and determine whether an item is current before further distribution. FDA sincerely regrets the error and has taken steps to resolve this technological glitch.
Full Article
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Mega Slim Herbal Appetite Management Pills by YoungYou International: Recall - Presence of DMAA
|
1/31/2014
|
|
6:40 PM
|
FDA MedWatch RSS Feed
|
DMAA may cause a rise in blood pressure or other cardiovascular problems such as shortness of breath, tightening in the chest or heart attack.
Full Article
|
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PMI Nutrition, LLC Recalls Red Flannel? Cat Food Due to Possible Salmonella Contamination
|
1/26/2014
|
|
9:58 PM
|
FDA Pet Health RSS Feed
|
PMI Nutrition, LLC (PMI), Arden Hills, Minn., has initiated a voluntary recall of its 20 lb. bags of Red Flannel? Cat Formula cat food for possible Salmonella contamination. There have been no reports of illness related to this product to date.
Full Article
|
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Trufill n-BCA Liquid Embolic System by Codman Neuro: Recall - Incorrect Instructions For Use
|
1/22/2014
|
|
6:50 PM
|
FDA MedWatch RSS Feed
|
Incorrectly mixed product can result in the liquid mixture solidifying too slowly and could result in significant impact to the patient, including neurological deficits, pulmonary emboli and possibly death.
Full Article
|
|
Dream Body Slimming Capsule: Public Notification - Undeclared Drug Ingredient
|
1/22/2014
|
|
3:25 PM
|
FDA MedWatch RSS Feed
|
Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.
Full Article
|
|
Magic Slim: Public Notification - Undeclared Drug Ingredient
|
1/22/2014
|
|
3:18 PM
|
FDA MedWatch RSS Feed
|
Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.
Full Article
|
|
StemAlive 90 Capsules: Recall - Contains Undeclared Milk
|
1/20/2014
|
|
1:30 AM
|
FDA MedWatch RSS Feed
|
Risk of serious or life-threatening allergic reaction.
Full Article
|
|
Rohto Eye Drops - Mentholatum: Recall - Sterility Control Review
|
1/17/2014
|
|
6:55 PM
|
FDA MedWatch RSS Feed
|
Production facility in Vietnam reviewing manufacturing sterility controls.
Full Article
|
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Acetaminophen Prescription Combination Drug Products with more than 325 mg: FDA Statement - Recommendation to Discontinue Prescribing and Dispensing
|
1/15/2014
|
|
12:10 AM
|
FDA MedWatch RSS Feed
|
Inadvertent overdose from prescription combination drugs containing acetaminophen accounts for nearly half of all cases of acetaminophen-related liver failure in the United States, some of which result in liver transplant or death.
Full Article
|
|
Pro ArthMax by Human Science Foundation: Recall - Undeclared Drug Ingredients
|
1/14/2014
|
|
5:40 PM
|
FDA MedWatch RSS Feed
|
Undeclared Chlorzoxazone, Nefopam, Diclofenac, Ibuprofen, Naproxen, and Indomethacin. Pro ArthMax has a reasonable probability of resulting in fatal adverse events.
Full Article
|
|
Boost Ultra, XZone Gold, Sexy Monkey, Triple MiracleZen Platinum, Magic for Men,"New" Extenze, and New XZen Platinum Marketed as Dietary Supplements: Recall - Undeclared Drug Ingredients
|
1/10/2014
|
|
10:00 PM
|
FDA MedWatch RSS Feed
|
Analysis found these products to contain undeclared Sildenafil and/or Tadalafil, may interact with nitrates found in some prescription drugs, and may lower blood pressure to dangerous levels.
Full Article
|
|
Puritan Bennett 840 Series Ventilator by Covidien - Class I Recall - Software Problem
|
1/10/2014
|
|
7:00 PM
|
FDA MedWatch RSS Feed
|
Ventilator may stop functioning, triggering the safety alarm and causing the patient to suddenly be required to breathe on his or her own.
Full Article
|
|
December 2013 - Drug Safety Labeling Changes
|
1/10/2014
|
|
5:50 AM
|
FDA MedWatch RSS Feed
|
Safety Labeling Changes includes 39 products with revisions to Prescribing Information.
Full Article
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|
Sodium Phosphate Over-the-Counter Products: Drug Safety Communication - Possible Harm From Exceeding Recommended Dose
|
1/8/2014
|
|
4:36 PM
|
FDA MedWatch RSS Feed
|
Reports of severe dehydration and changes in the levels of serum electrolytes from taking more than the recommended dose, resulting in serious adverse effects, in some cases resulting in death.
Full Article
|
|
Truebalance and Truetrack Blood Glucose Meters by Nipro Diagnostics: Recall - Incorrect Factory-set Measure
|
1/8/2014
|
|
1:48 PM
|
FDA MedWatch RSS Feed
|
If a consumer were not to notice the incorrect unit of measure, it is possible that the meter result could be read as a lower than expected blood glucose result.
Full Article
|
|
SafeSpout and SafeShower Filtration Products by Nephros: Class I Recall - Exposure to Bacteria or Virus
|
1/7/2014
|
|
6:48 PM
|
FDA MedWatch RSS Feed
|
The fiber filter or the sealing compound, holding the fiber in place, could break apart, exposing patients to bacteria or viruses, which could result in infection or death.
Full Article
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|
Nephros Filtration Products: Class I Recall - Labeling Promoting Medical Claims
|
1/7/2014
|
|
4:30 PM
|
FDA MedWatch RSS Feed
|
Promotional materials for non-medical water filtration products were determined to promote claims which constitute marketing the product as a medical device.
Full Article
|
|
CLINIMIX and CLINIMIX E Injection/Baxter: Recall - Particulate Matter in Products
|
1/6/2014
|
|
12:15 PM
|
FDA MedWatch RSS Feed
|
If infused, particulate matter may result in blockages of blood vessels, which can result in stroke, heart attack, or damage to other organs such as the kidney or liver.
Full Article
|
|
CO2 Multi Absorber by Vital Signs Devices: Field Corrective Action - Loss of Anesthetic Gases, Ventilation and Oxygenation
|
1/1/2014
|
|
11:00 PM
|
FDA MedWatch RSS Feed
|
A potential safety issue due to air leakage associated with the CO2 Multi Absorber.
Full Article
|
|
Baxter 5 Percent Dextrose Injection, USP And 0.9 Percent Sodium Chloride Injection, USP Intravenous (IV) Solutions: Recall - Particulate Matter In Solution
|
12/27/2013
|
|
3:48 PM
|
FDA MedWatch RSS Feed
|
Injecting a product containing particulate matter may result in blockages of blood vessels, which can result in stroke, heart attack or damage to other organs such as the kidney or liver.
Full Article
|
|
Burn 7 Capsules by Deseo Rebajar: Recall - Undeclared Drug Ingredient
|
12/24/2013
|
|
9:00 PM
|
FDA MedWatch RSS Feed
|
Undeclared Sibutramine, known to substantially increase blood pressure and/or pulse rate in some patients.
Full Article
|
|
Lidocaine HCl Injection 2%, 5 ml Vial by Hospira: Recall - Presence of Particulate Matter
|
12/24/2013
|
|
3:00 PM
|
FDA MedWatch RSS Feed
|
If infused, particulate matter could lead to local inflammation, tissue trauma, mechanical disruption of tissue, and/or local granuloma formulation.
Full Article
|
|
Muscle Growth Product Called Mass Destruction: FDA Health Risk Warning - Undeclared Ingredients
|
12/23/2013
|
|
9:00 PM
|
FDA MedWatch RSS Feed
|
The product is labeled to contain at least one synthetic anabolic steroid and has been linked to at least one reported serious illness.
Full Article
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|
Abrams Royal Pharmacy Sterile Products - Recall - Lack of Sterility Assurance
|
12/19/2013
|
|
5:01 PM
|
FDA MedWatch RSS Feed
|
Use of Microbial contamination in products intended to be sterile can put patients at risk for serious, potentially life-threatening infections.
Full Article
|
|
Methylphenidate ADHD Medications: Drug Safety Communication - Risk of Long-lasting Erections
|
12/17/2013
|
|
3:40 PM
|
FDA MedWatch RSS Feed
|
Prolonged erections (priapism) can lead to permanent damage to the penis.
Full Article
|
|
Soliris (Eculizumab) Concentrated Solution for Intravenous Infusion by Alexion: Recall - Visible Particles
|
12/16/2013
|
|
3:10 PM
|
FDA MedWatch RSS Feed
|
Two lots were found to contain visible particles. Particulates could cause blockage of flow of blood in vessels, which could be life-threatening.
Full Article
|
|
Nipple Aspirate Test: Safety Communication - Breast Cancer Screening Test Is Not An Alternative To Mammography
|
12/12/2013
|
|
8:15 PM
|
FDA MedWatch RSS Feed
|
Misleading claims about a nipple aspirate test may lead patients to not get mammograms and/or other needed breast imaging tests or biopsies. This may lead to serious adverse health consequences.
Full Article
|
|
Cargill Conducts Voluntary Recall of Select Nutrena? NatureWise? Meatbird and Chick Starter Feed
|
12/4/2013
|
|
3:28 AM
|
FDA Pet Health RSS Feed
|
Cargill's animal nutrition business today announced a voluntary recall of two of its Nutrena NatureWise poultry feeds due to incorrect levels of calcium. The affected products were manufactured at Cargill's facilities in Flora, Ill., Oklahoma City, Okla., Abilene, Texas, and Mineola, Texas, between May 1, 2013 and Nov. 21, 2013.
Full Article
|
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Onfi (clobazam): Drug Safety Communication - Risk of Serious Skin Reactions
|
12/3/2013
|
|
3:22 PM
|
FDA MedWatch RSS Feed
|
Cases of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) Reported.
Full Article
|
|
HeartStart Automated External Defibrillators (AED) From Philips Healthcare: Safety Communication - Failure Of An Electrical Component That Could Cause AEDs To Fail To Deliver Appropriate Shock
|
12/3/2013
|
|
5:00 AM
|
FDA MedWatch RSS Feed
|
When normal heart rhythms are not restored quickly, sudden cardiac arrest can cause death.
Full Article
|
|
Hydravax Dietary Supplement by IQ Formulations: Recall - Possible Undeclared Drug Ingredient
|
12/1/2013
|
|
11:30 PM
|
FDA MedWatch RSS Feed
|
Sample from one lot of Hydravax revealed the presence of a diuretic. Possible effects of using a diuretic include an electrolyte imbalance due to water loss.
Full Article
|
|
FreeStyle and FreeStyle Lite Blood Glucose Test Strips by Abbott: Recall - Erroneously Low Blood Glucose Results
|
11/28/2013
|
|
10:20 PM
|
FDA MedWatch RSS Feed
|
Falsely low blood glucose results can lead patients to try to raise their blood glucose when it is
unnecessary, or to fail to treat elevated blood glucose due to a falsely low reading.
Full Article
|
|
Nitroglycerin in 5% Dextrose Injection by Baxter: Recall - Particulate Matter
|
11/27/2013
|
|
7:00 PM
|
FDA MedWatch RSS Feed
|
Voluntary recall of one lot due to particulate matter found in one vial. If infused, particulate matter could lead to potential venous and/or arterial thromboembolism.
Full Article
|
|
Spacelabs Healthcare, Inc., Spacelabs Anesthesia Workstations and Service Kits: Class I Recall - Bag-to-Vent Switch in CAS I/II Absorbers May Fail
|
11/26/2013
|
|
2:00 PM
|
FDA MedWatch RSS Feed
|
Potential for a large leak from the absorber circuit while operating in bag mode and could impede the ability to provide ventilation in bag mode.
Full Article
|
|
CLR Medicals International Inc. Viscoelastic Products: Recall - Quality System Deficiencies And Lack Of Premarket Approval (PMR)
|
11/26/2013
|
|
1:15 PM
|
FDA MedWatch RSS Feed
|
Clinical consequences associated with use of the contaminated and/or adulterated products may include intraocular infection, inflammation and elevated intraocular pressure.
Full Article
|
|
Rosiglitazone-containing Diabetes Medicines: Drug Safety Communication - Removal of Some Prescribing and Dispensing Restrictions
|
11/25/2013
|
|
8:00 PM
|
FDA MedWatch RSS Feed
|
Health care professionals, pharmacies, and patients will no longer be required to enroll in the rosiglitazone REMS program to be able to prescribe, dispense, or receive rosiglitazone medicines.
Full Article
|
|
Hospira GemStar Infusion System: Class I Recall - Pressure Sensor Calibration Drift
|
11/25/2013
|
|
9:55 AM
|
FDA MedWatch RSS Feed
|
May result in a delay, interruption or over-infusion in therapy, which have a worst case potential to result in significant injury or death depending on the drug and the dosage administered.
Full Article
|
|
Meridian Medical Technologies Auto-Injectors: Extension of Expiration Dates
|
11/22/2013
|
|
10:00 PM
|
FDA MedWatch RSS Feed
|
FDA is currently reviewing data for the potential use of these auto-injectors beyond their labeled expiration dates, in order to mitigate any potential shortages.
Full Article
|
|
Adipotrim XT by Deseo Rebajar: Recall - Undeclared Drug Ingredient
|
11/21/2013
|
|
9:20 PM
|
FDA MedWatch RSS Feed
|
Undeclared Fluoxetine, a selective serotonin reuptake inhibitor (SSRI). Use of SSRIs have been associated with serious side effects including suicidal thinking, abnormal bleeding, and seizures.
Full Article
|
|
Lexiscan (regadenoson) and Adenoscan (adenosine): Drug Safety Communication - Rare but Serious Risk of Heart Attack and Death
|
11/20/2013
|
|
9:00 PM
|
FDA MedWatch RSS Feed
|
Cases of myocardial infarction and death have occurred following the administration of Lexiscan (regadenoson) injection or Adenoscan (adenosine) infusion.
Full Article
|
|
P-Boost, NatuRECT by Tendex: Recall - Undeclared Drug Ingredient
|
11/20/2013
|
|
7:15 PM
|
FDA MedWatch RSS Feed
|
Undeclared tadalafil may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to unsafe levels.
Full Article
|
|
RezzRX: Recall - Undeclared Drug Ingredients
|
11/19/2013
|
|
8:30 PM
|
FDA MedWatch RSS Feed
|
Undeclared hydroxylthiohomosildenafil and aminotadalafil (PDE-5) inhibitors may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to unsafe levels.
Full Article
|
|
Rhino 5 Plus, Maxtremezen and Extenzone: Recall - Undeclared Drug Ingredients
|
11/19/2013
|
|
8:15 PM
|
FDA MedWatch RSS Feed
|
Undeclared Desmethylcarbondenafil, a posphodiesterase (PDE-5) inhibitor, and dapoxetine, an ingredient not approved by the FDA, may present a health risk which could be life threatening.
Full Article
|
|
Nature's Pharmacy and Compounding Center Sterile Compounded Products: Recall - Lack of Sterility Assurance
|
11/16/2013
|
|
7:05 PM
|
FDA MedWatch RSS Feed
|
In the event a sterile product is compromised, patients are at risk for very serious infections.
Full Article
|
|
New Reliance Traders, Inc. Special Eyeliner: Recall - Elevated Lead Levels
|
11/16/2013
|
|
3:15 AM
|
FDA MedWatch RSS Feed
|
Recent analysis of the product found that the products contained lead levels high as 167387 parts per million (ppm)
Full Article
|
|
Medtronic Guidewires: Recall - Potential For Coating On Surface To Delaminate And Detach
|
11/16/2013
|
|
2:30 AM
|
FDA MedWatch RSS Feed
|
Some Medtronic models of its guidewires from recent lots have the potential for the coating on their surface to
delaminate and detach.
Full Article
|
|
Nature's Pharmacy and Compounding Center Issues Voluntary Recall of All Sterile Compounded Products Distributed Within North Carolina Due to Lack of Sterility Assurance
|
11/15/2013
|
|
11:35 PM
|
FDA Pet Health RSS Feed
|
ature's Pharmacy and Compounding Center of Asheville, NC is voluntarily recalling of all lots of sterile products compounded by the pharmacy that are not expired to the consumer level. The product will be in the form of an injectable drug or an eye drop.
Full Article
|
|
VitaliKOR Fast Acting: Recall - Undeclared Drug Ingredients
|
11/15/2013
|
|
4:15 PM
|
FDA MedWatch RSS Feed
|
Undeclared Vardenafil and Tadalafil may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to unsafe levels.
Full Article
|
|
Over-the-Counter Topical Antiseptic Products: Drug Safety Communication - FDA Requests Label Changes and Single-Use Packaging to Decrease Risk of Infection
|
11/13/2013
|
|
11:22 PM
|
FDA MedWatch RSS Feed
|
Clinical infections have also been reported to FDA, leading to some product recalls. The reported outcomes ranged from localized infections at injection sites to systemic infections that resulted in death.
Full Article
|
|
Vega One Nutritional Shakes and Vega Sport Performance Protein: Recall - Traces of Antibiotic
|
11/12/2013
|
|
6:35 PM
|
FDA MedWatch RSS Feed
|
Risk of aplastic anemia and allergic reactions.
Full Article
|
|
OxyElite Pro Dietary Supplements by USP Labs: Recall - Products Linked to Liver Illnesses
|
11/10/2013
|
|
4:35 PM
|
FDA MedWatch RSS Feed
|
The products contained aegeline, a new dietary ingredient that lacks a history of use or other evidence of safety.
Full Article
|
|
Bailey?s Choice Expands Product Recall of Dog Treats in Georgia
|
11/7/2013
|
|
3:50 PM
|
FDA Pet Health RSS Feed
|
Agriculture Commissioner Gary W. Black is alerting Georgians to the expanded recall of particular packages of Bailey?s Choice dog treats sold in Georgia. These products have the potential to be contaminated with Salmonella and should be discarded.
Full Article
|
|
Baylis Medical TorFlex Transseptal Guiding Sheath Kit: Class I Recall - Sheath Could Remove Particulate
|
11/6/2013
|
|
9:30 PM
|
FDA MedWatch RSS Feed
|
Particulate could potentially migrate into a patient?s bloodstream.
Full Article
|
|
Low Molecular Weight Heparins: Drug Safety Communication - Recommendations to Decrease Risk of Spinal Column Bleeding and Paralysis
|
11/6/2013
|
|
6:50 PM
|
FDA MedWatch RSS Feed
|
All anticoagulants carry the risk of causing epidural or spinal hematomas when used in conjunction with epidural/spinal anesthesia or spinal puncture.
Full Article
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Edwards Lifesciences LLC, EMBOL-X Glide Protection System: Class I Recall - Deformed Cannula Tip
|
11/4/2013
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|
8:11 PM
|
FDA MedWatch RSS Feed
|
Use of defective product may lead to tip separation and embolization.
Full Article
|
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Perrigo Acetaminophen Infant Suspension Liquid: Recall - Potential Defect with Co-packaged Oral Syringe
|
11/2/2013
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|
4:00 AM
|
FDA MedWatch RSS Feed
|
Using an oral syringe without dose markings can result in inaccurate dosing, especially in infants who could mistakenly get too high a dose. Posted 11/02/2013
Full Article
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September 2013 - Drug Safety Labeling Changes
|
11/1/2013
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8:10 PM
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FDA MedWatch RSS Feed
|
September 2013 drug safety labeling changes
Full Article
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Potiga (Ezogabine): Drug Safety Communication - Linked To Retinal Abnormalities And Blue Skin Discoloration
|
11/1/2013
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|
5:00 PM
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FDA MedWatch RSS Feed
|
UPDATE: Boxed Warning and other labeling changes approved.
Full Article
|
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PENTAX Medical Gas/Water Valves, Model OF-B194: Recall - Manufacturing Defect
|
11/1/2013
|
|
4:45 PM
|
FDA MedWatch RSS Feed
|
May prevent users from turning off CO2 gas flow during an endoscopic procedure, leading to risk of peritonitis, perforations, sepsis, death, and bowel perforations requiring surgical repair.
Full Article
|
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MedStream Programmable Infusion Pump and Refill Kits by Codman and Shurtleff: Class 1 Recall - Drug Over Infusion
|
10/23/2013
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|
6:15 PM
|
FDA MedWatch RSS Feed
|
Air in the pump reservoir may release a higher dosage of drug than expected, leading to drug overdose.
Full Article
|
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Specialty Medicine Compounding Pharmacy Certain Unexpired Compounded Sterile Products: Recall - Particulate Matter Found in Vials
|
10/21/2013
|
|
4:00 AM
|
FDA MedWatch RSS Feed
|
If there is microbial contamination in products intended to be sterile, patients are at risk for serious, potentially life-threatening infections. Posted 10/21/2013
Full Article
|
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Bard LifeStent Solo Vascular Stent: Class 1 Recall - Failure to Deploy
|
10/18/2013
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|
11:20 PM
|
FDA MedWatch RSS Feed
|
Serious adverse health consequences, including complications of bleeding, loss of limb, heart attack, or stroke.
Full Article
|
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Albuterol Sulfate Inhalation Solution, 0.083 percent (Nephron Pharmaceuticals): Recall - Aseptic Processing Simulation Results
|
10/17/2013
|
|
7:30 PM
|
FDA MedWatch RSS Feed
|
Finding of bacterial growth.
Full Article
|
|
St. Jude Amplatzer Atrial Septal Occluder (ASO): Safety Communication - Reports of Tissue Erosion
|
10/17/2013
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|
7:00 PM
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FDA MedWatch RSS Feed
|
Tissue surrounding the Amplatzer ASO can break down (erode) and result in life-threatening emergencies that require immediate surgery.
Full Article
|
|
Engström Ventilator, Aespire View, Aisys, And Avance Anesthesia Machines: Voluntary Field Corrective Action - Potential Safety Issue
|
10/16/2013
|
|
11:25 PM
|
FDA MedWatch RSS Feed
|
May result in the inability to access certain menu functions which could possibly lead to delay in treatment.
Full Article
|
|
Avance, Aisys And Avance CS2 Anesthesia Delivery Systems: Voluntary Field Corrective Action - Potential Safety Issue
|
10/15/2013
|
|
4:00 AM
|
FDA MedWatch RSS Feed
|
A unique sequence of inputs and a collapsed bellow could result in delivery of higher-than-expected tidal volume.
Full Article
|
|
Inclusig (Ponatinib): Drug Safety Communication - Increased Reports Of Serious Blood Clots In Arteries And Veins
|
10/11/2013
|
|
2:30 PM
|
FDA MedWatch RSS Feed
|
Health care professionals should consider for each patient, whether the benefits of Iclusig treatment are likely to exceed the risks of treatment.
Full Article
|
|
Perfect Body Solutions and Burn 7: Public Notification - Undeclared Ingredients
|
10/10/2013
|
|
6:20 PM
|
FDA MedWatch RSS Feed
|
May increase blood pressure and/or pulse rate and can present a significant risk for patients with a history certain cardiovascular conditions or stroke.
Full Article
|
|
Dr. Mao Slimming Capsules: Public Notification - Undeclared Ingredients
|
10/10/2013
|
|
6:00 PM
|
FDA MedWatch RSS Feed
|
May increase blood pressure and/or pulse rate and can present a significant risk for patients with a history certain cardiovascular conditions or stroke.
Full Article
|
|
Bella Vi Insane Amp’d And Bella Vi Amp’d Up: Public Notification - Undeclared Ingredients
|
10/10/2013
|
|
5:15 PM
|
FDA MedWatch RSS Feed
|
May increase blood pressure and/or pulse rate and can present a significant risk for patients with a history certain cardiovascular conditions or stroke.
Full Article
|
|
Be Inspired: Public Notification - Undeclared Ingredients
|
10/10/2013
|
|
5:44 AM
|
FDA MedWatch RSS Feed
|
May increase blood pressure and/or pulse rate and can present a significant risk for patients with a history certain cardiovascular conditions or stroke.
Full Article
|
|
Slim Fortune, Lidiy And Slim Expert Dietary Supplement: Recall - Undeclared Ingredients
|
10/9/2013
|
|
9:45 PM
|
FDA MedWatch RSS Feed
|
May substantially increase blood pressure and/or pulse rate or present a significant risk for patients with a history of certain cardiovascular conditions or stroke.
Full Article
|
|
Cefepime For Injection, USP And Dextrose Injection, USP By B. Braun Medical Inc.: Recall - Visible Particulate Matter
|
10/8/2013
|
|
9:20 PM
|
FDA MedWatch RSS Feed
|
May illicit inflammatory responses, both chronic and acute, and may be life threatening.
Full Article
|
|
OxyElite Pro: Health Advisory - Acute Hepatitis Illness Cases Linked To Product Use
|
10/8/2013
|
|
8:00 PM
|
FDA MedWatch RSS Feed
|
FDA advises consumers to stop using products labeled OxyElite Pro while the investigation continues.
Full Article
|
|
Fabius Anesthesia Machines: Recall - Did Not Pass High Voltage Test Portion Of Final Production Test
|
10/8/2013
|
|
5:20 PM
|
FDA MedWatch RSS Feed
|
In extreme cases, may cause a failure of the automatic ventilation function of the device.
Full Article
|
|
Breast Health Test and the Mammary Aspiration Specimen Cytology Test (MASCT): Recall - Concerns With Instructions For Use, Promotional Claims and FDA Clearance
|
10/5/2013
|
|
1:15 AM
|
FDA MedWatch RSS Feed
|
Atossa will remove existing product from the market until concerns are addressed.
Full Article
|
|
1% Lidocaine HCL Injection By Hospira: Recall - Presence Of Dark Particulate
|
10/5/2013
|
|
12:45 AM
|
FDA MedWatch RSS Feed
|
May result in local inflammation, phlebitis, and/or low-level allergic response, and could block administration of the drug to the patient, causing a delay in therapy.
Full Article
|
|
Emergency Cricothyrotomy Kit By H&H Medical Corporation: Recall - Defective Cuff Balloon On Endotracheal Airway
|
10/4/2013
|
|
10:45 PM
|
FDA MedWatch RSS Feed
|
Defect due to a reduction in package density, a higher than average dose of gamma sterilization, and the occasional slippage of a protective silicon sleeve during shipping.
Full Article
|
|
Metoclopramide Injection And Ondansetron Injection by Hospira: Recall - Glass Strand Particulates Caused By Glass Supplier
|
10/2/2013
|
|
4:10 PM
|
FDA MedWatch RSS Feed
|
Administration of an injectable with the presence of foreign particulates may result in local inflammation,
thrombophlebitis, and/or low-level allergic response.
Full Article
|
|
Virilis Pro, PHUK and Prolifta Capsules : Recall - Undeclared Ingredients
|
10/1/2013
|
|
2:15 PM
|
FDA MedWatch RSS Feed
|
Potential to interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to unsafe levels.
Full Article
|
|
Carefusion Avea Ventilator: Recall - Underreporting Of Tidal Volume If Used In Conjunction With Neonatal Hotwire Flow Sensor
|
10/1/2013
|
|
1:50 PM
|
FDA MedWatch RSS Feed
|
Patients may receive a higher than expected tidal
Full Article
|
|
Afikim Electric Vehicles Issues Nationwide Recall Of Breeze C Scooter: Recall - Potential For Malfunction
|
10/1/2013
|
|
1:30 PM
|
FDA MedWatch RSS Feed
|
May become unresponsive during operation, resulting in the driver not being able to stop the scooter during operation.
Full Article
|
|
Tygacil (tigecycline): Drug Safety Communication - Increased Risk of Death
|
9/27/2013
|
|
3:15 PM
|
FDA MedWatch RSS Feed
|
BOXED WARNING describes risk for FDA-approved and non-approved uses.
Full Article
|
|
The Compounding Shop: FDA News Release - Lack of Sterility Assurance of Drug Products
|
9/27/2013
|
|
3:00 PM
|
FDA MedWatch RSS Feed
|
UPDATED 09/27/2013. Budesonide solution, used for nasal irrigation, from The Compounding Shop may be contaminated and should not be used or administered to patients. Originally posted 05/08/2013
Full Article
|
|
W.S. Badger Company Daily SPF 30 Kids & Baby Sunscreen Lotion: Recall - Microbial Contamination
|
9/25/2013
|
|
7:30 PM
|
FDA MedWatch RSS Feed
|
Lab testing found certain product lots were contaminated with Pseudomonas aeruginosa, Candida parapsilosis and Acremonium fungi.
Full Article
|
|
Arzerra (ofatumumab) and Rituxan (rituximab): Drug Safety Communication - New Boxed Warning, Recommendations to Decrease Risk of Hepatitis B Reactivation
|
9/25/2013
|
|
3:50 PM
|
FDA MedWatch RSS Feed
|
Hepatitis B reactivation occurred in patients with prior HBV exposure and later treated with Arzerra & Rituxan. Cases of fulminant hepatitis, hepatic failure, and death reported.
Full Article
|
|
Xzen 1200, Xzen Gold and Xzen XPress: Public Notification - Undeclared Ingredients
|
9/24/2013
|
|
7:35 PM
|
FDA MedWatch RSS Feed
|
May interact with nitrates found in some prescription drugs lower blood pressure to dangerous levels.
Full Article
|
|
XZone Premium: Public Notification - Undeclared Drug Ingredient
|
9/24/2013
|
|
7:30 PM
|
FDA MedWatch RSS Feed
|
Contains contains sildenafil and tadalafil, which may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels.
Full Article
|
|
Wood-E: Public Notification - Undeclared Drug Ingredient
|
9/24/2013
|
|
7:25 PM
|
FDA MedWatch RSS Feed
|
Contains sildenafil, which may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels.
Full Article
|
|
Duragesic (fentanyl) Patches: Drug Safety Communication - Packaging Changes to Minimize Risk of Accidental Exposure
|
9/23/2013
|
|
4:30 PM
|
FDA MedWatch RSS Feed
|
Accidental exposure to fentanyl can cause serious harm and death in children, pets, and others.
Full Article
|
|
Baxter Dual Luer Lock Caps: Class I Recall - Presence of Loose Particulate Matter Found In Packaging
|
9/20/2013
|
|
1:30 PM
|
FDA MedWatch RSS Feed
|
May result in thrombotic and embolic events, including: pulmonary embolism, myocardial infarction and stroke.
Full Article
|
|
Shou Fu Ti Tun Guo Xiang Xing Jian Fei Jiao Nang: Public Notification - Undeclared Drug Ingredient
|
9/17/2013
|
|
7:20 PM
|
FDA MedWatch RSS Feed
|
May substantially increase blood pressure and/or pulse rate in some patients and presents a risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.
Full Article
|
|
HeartSine Technologies Samaritan 300/300P PAD Public Access Defibrillators: Recall - Power, Battery Issues
|
9/17/2013
|
|
12:00 PM
|
FDA MedWatch RSS Feed
|
Two separate issues may affect the ability to deliver therapy to a patient in a sudden cardiac arrest event.
Full Article
|
|
Bupivacaine HCL Injection 0.25% (2.5 MG/ML) and Bupivacaine HCL 0.75% (7.5 MG/ML), 30 ML Single-Dose Vials by Hospira, Inc.: Recall- Presence of Particulate Matter
|
9/14/2013
|
|
12:20 AM
|
FDA MedWatch RSS Feed
|
One lot of each strength recalled, administration of an injectable with the presence of foreign particulates may potentially cause thrombophlebitis, bacteremia, sepsis, and/or endocarditis and death may result.
Full Article
|
|
Creafuse Powder Grape and Creafuse Powder Fruit Punch: Recall - Contains DMAA
|
9/13/2013
|
|
4:52 PM
|
FDA MedWatch RSS Feed
|
Ingestion of DMAA can elevate blood pressure and lead to cardiovascular problems.
Full Article
|
|
Leiter's Compounding Pharmacy: Recall - Concerns of Sterility Assurance
|
9/12/2013
|
|
4:30 PM
|
FDA MedWatch RSS Feed
|
Use of a non-sterile injectable product exposes patients to the risk of contracting serious life-threatening infections.
Full Article
|
|
Park Compounding Sterile Medication: Recall ? Concerns of Sterility Assurance
|
9/10/2013
|
|
4:00 AM
|
FDA MedWatch RSS Feed
|
If there is microbial contamination in products intended to be sterile, patients are at risk of serious infections which may be life threatening.
Full Article
|
|
Avella Specialty Pharmacy Sterile Medications: Recall - Concerns Of Sterility Assurance At Testing Vendor
|
9/9/2013
|
|
8:20 PM
|
FDA MedWatch RSS Feed
|
If microbial contamination occurs in medications intended to be sterile, patients are at risk of serious infections that may be life threatening.
Full Article
|
|
MOTRIN Infants Drops Original Berry Flavor 1/2 fl oz: Recall - Particles Identified
|
9/8/2013
|
|
4:00 AM
|
FDA MedWatch RSS Feed
|
May contain tiny plastic particles.
Full Article
|
|
Altaire Pharmaceuticals Carboxymethylcellulose Sodium 0.5 Percent Ophthalmic Solution Sold Under Wal-Mart, CVS, and Target Brands: Recall - Preservative May Not Be Effective Through Expiry
|
9/8/2013
|
|
4:00 AM
|
FDA MedWatch RSS Feed
|
Potential risk for eye infection.
Full Article
|
|
University Compounding Pharmacy Injection Products: Recall - Lack of Sterility Assurance
|
9/8/2013
|
|
4:00 AM
|
FDA MedWatch RSS Feed
|
If there is microbial contamination in products intended to be sterile, patients are at risk of serious infections which may be life threatening.
Full Article
|
|
Medaus Pharmacy Sterile Compounded Products - Recall: Inability to Confirm Sterility
|
9/5/2013
|
|
9:45 PM
|
FDA MedWatch RSS Feed
|
Questions Surrounding an Independent Third Party's Sterility Testing
Full Article
|
|
Hubbard Feeds Inc. Announces an Expanded Voluntary Recall of Hubbard Life Homestead FastGrow Poultry Feed in Indiana, Michigan and Illinois Due to Elevated Calcium
|
9/5/2013
|
|
1:51 AM
|
FDA Pet Health RSS Feed
|
Hubbard Feeds Inc. announced today a voluntary recall of three additional lots of Hubbard Life Homestead FASTGROW AM.0.0125 NAB/NAB MEDICATED because of elevated calcium levels that may be harmful to chickens and turkeys. This voluntary recall is the result of identification of additional lot numbers through assays by the FDA related to a voluntary recall of the same product on July 2, 2013. No adverse events or complaints have been reported to date for the three additional lots listed below.
Full Article
|
|
Siemens MicroScan Synergies Plus And MicroScan RapID/S Plus Negative Panels: Class I Recall - False Susceptible And False Intermediate Results
|
9/4/2013
|
|
5:40 PM
|
FDA MedWatch RSS Feed
|
Defect may lead to treatment with an inappropriate antibiotic or a delay in initiating appropriate therapy.
Full Article
|
|
Aminosyn II 10 percent, Sulfite-Free (Hospira): Recall - Particulate Matter Noted in One Lot
|
9/3/2013
|
|
12:35 PM
|
FDA MedWatch RSS Feed
|
Particle confirmed by Hospira as human hair.
Full Article
|
|
Nestle Purina Voluntarily Recalls Limited Number of Purina ONE beyOnd Our White Meat Chicken and Whole Barley Recipe Adult Dry Dog Food Bags Due to a Potential Health Risk
|
8/30/2013
|
|
8:31 PM
|
FDA Pet Health RSS Feed
|
St. Louis, Missouri, Nestle Purina PetCare Company (NPPC) is voluntarily recalling a limited number of 3.5-pound bags of its Purina ONE beyOnd Our White Meat Chicken and Whole Barley Recipe Adult Dry Dog Food from a single production run and shipped to retail customers in the United States. This is being done because one bag of the product was found to be contaminated with Salmonella.
Full Article
|
|
Cubicin (daptomycin for injection): Recall - Glass Particulate Matter Present in Four Lots
|
8/29/2013
|
|
6:00 PM
|
FDA MedWatch RSS Feed
|
Risk of thromboembolism and pulmonary
emboli, some life-threatening.
Full Article
|
|
Gilenya (fingolimod) - Drug Safety Communication: Investigating Rare Brain Infection
|
8/29/2013
|
|
3:00 PM
|
FDA MedWatch RSS Feed
|
Patient has developed a rare and serious brain infection after taking the drug.
Full Article
|
|
Stryker Spine: Class 1 Recall - OASYS Midline Occiput Plate
|
8/29/2013
|
|
1:30 PM
|
FDA MedWatch RSS Feed
|
Post-operative fracture of the pin that connects the head to the plate body.
Full Article
|
|
Goldenfeast? Inc. Recalls Bird Food Due to Possible Salmonella Contamination from Parsley
|
8/28/2013
|
|
12:51 PM
|
FDA Pet Health RSS Feed
|
Goldenfeast? Inc. is recalling several exotic bird food blends due to possible contamination of Salmonella from parsley flake ingredients supplied to Goldenfeast? Inc. by Specialty Commodities, Inc., an outside supplier to Goldenfeast? Inc.
Full Article
|
|
Pro Power Max, Evil Root and 72HP By Hardmenstore.com: Recall - Undeclared Ingredient
|
8/28/2013
|
|
12:00 AM
|
FDA MedWatch RSS Feed
|
May interact with nitrates found in some prescription drugs,lower blood pressure to dangerous levels or cause
side effects, such as headaches and flushing.
Full Article
|
|
Wellness Pharmacy, Inc. Products: Recall - Laboratory Results Indicating Microbial Contamination
|
8/27/2013
|
|
8:30 PM
|
FDA MedWatch RSS Feed
|
If there is microbial contamination in medications intended to be sterile, patients are at risk of serious infections which may be life threatening.
Full Article
|
|
JCB Laboratories Products: Recall - Sterility Assurance at Testing Vendor
|
8/27/2013
|
|
7:45 PM
|
FDA MedWatch RSS Feed
|
If there is microbial contamination in products intended to be sterile, patients are at risk for serious, potentially life-threatening infections.
Full Article
|
|
Compounded Sterile Preparations By Park Pharmacy & Compounding Center: Recall - Lack of Sterility Assurance
|
8/27/2013
|
|
3:00 PM
|
FDA MedWatch RSS Feed
|
Methods used by the laboratory to assess sterility may have resulted in pharmacies receiving inaccurate laboratory test results.
Full Article
|
|
Ortiga Contains Hidden Drug Ingredient
|
8/22/2013
|
|
6:45 PM
|
FDA MedWatch RSS Feed
|
FDA laboratory analysis confirmed that Ortiga contains the prescription drug
ingredient, diclofenac.
Full Article
|
|
Jack Rabbit Dietary Supplement: Recall - Undeclared Drug Ingredients
|
8/21/2013
|
|
12:40 PM
|
FDA MedWatch RSS Feed
|
Undeclared Sildenafil and Tadalafil may interact with nitrates found in some prescription drugs such as nitroglycerin, and may lower blood pressure to dangerous levels.
Full Article
|
|
Covidien Monoject Prefill Flush Syringes: Recall - Not Subjected To AutoClave Sterilization Process Or Mismatched Syringe Tip Cap, Syringe Label, Filled Volume And Wrapper
|
8/20/2013
|
|
5:10 PM
|
FDA MedWatch RSS Feed
|
Health risk of life-threatening infection to the blood stream or patency of device may not be maintained and clotting may occur.
Full Article
|
|
Esbelder Man Capsules, Esbelder Fem Capsules, And Esbelder Siloutte Capsules Vitamin Supplements By Herbal Give Care LLC: Recall - Undeclared Ingredients
|
8/20/2013
|
|
2:00 PM
|
FDA MedWatch RSS Feed
|
May substantially increase blood pressure and/or pulse rate as well as present significant other health risks for patients.
Full Article
|
|
Aidapak Services LLC, Select Repackaged Pharmaceuticals: Recall - Potential Incorrect Labeling
|
8/17/2013
|
|
2:00 PM
|
FDA MedWatch RSS Feed
|
Aidapak Services LLC, Specific Unit Dose Repackaged Products: Recall - Potential Incorrect Labeling
Full Article
|
|
Fluoroquinolone Antibacterial Drugs: Drug Safety Communication- Risk for possibly permanent nerve damage
|
8/15/2013
|
|
7:45 PM
|
FDA MedWatch RSS Feed
|
The risk of peripheral neuropathy occurs only with fluoroquinolones that are taken by mouth or by injection.
Full Article
|
|
P&G Voluntarily Recalls Limited Quantity of Dry Pet Food Due to Possible Health Risk
|
8/15/2013
|
|
3:58 AM
|
FDA Pet Health RSS Feed
|
The Procter & Gamble Company (P&G) has voluntarily recalled specific lots of dry pet food because they have the potential to be contaminated with Salmonella. These lots were distributed in the United States and represent roughly one-tenth of one percent (0.1%) of annual production.
Full Article
|
|
Hospira Blood Sets: Recall - Instances Of Outer Wall Of Blood Bags Punctured With Piercing Pin
|
8/14/2013
|
|
12:50 PM
|
FDA MedWatch RSS Feed
|
Spillage of the blood and blood products stored in the bag may result in delay/interruption in therapy or exposure to the healthcare professional.
Full Article
|
|
Iradimed Corporation, MRidium 3860+ Infusion Systems equipped with MRidium 1145 Dose Error Reduction System (DERS) Drug Library Kit: Class I Recall - Potential for Incorrect Recommended Infusion Rate
|
8/12/2013
|
|
2:08 PM
|
FDA MedWatch RSS Feed
|
Increased risk of over-infusion or under-infusion if the infusion is started with the incorrect rate. This can cause serious adverse health consequences, including death.
Full Article
|
|
Specialty Compounding Sterile Products: FDA Alert - Bacterial Infections
|
8/9/2013
|
|
6:25 PM
|
FDA MedWatch RSS Feed
|
Bacterial infections have been potentially associated with contaminated calcium gluconate infusions.
Full Article
|
|
Cordis Optease Retrievable Inferior Vena Cava (IVC) Filter: Recall - Labeling Correction
|
8/8/2013
|
|
6:54 PM
|
FDA MedWatch RSS Feed
|
The company is making corrections and improvements to the device labeling to minimize likelihood of implanting the filter backwards.
Full Article
|
|
CareFusion Alaris PC unit (model 8015) with version 9.12 Keyboard Processor: Class I Recall - Potential Loss of Communication Between Main Processor and Keyboard
|
8/7/2013
|
|
8:57 PM
|
FDA MedWatch RSS Feed
|
Device malfunction can result in the sudden unintended discontinuation of medications. This can lead to cause serious adverse health consequences, including death.
Full Article
|
|
Tranquility by Health and Beyond, LLC: Recall - Undeclared Drug Ingredient
|
8/7/2013
|
|
9:10 AM
|
FDA MedWatch RSS Feed
|
Consuming this product potentially could result in dizziness and cause public health risk.
Full Article
|
|
BEST SLIM 40 Pills By CTV Best Group: Recall - Undeclared Ingredients
|
8/6/2013
|
|
9:30 PM
|
FDA MedWatch RSS Feed
|
Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk.
Full Article
|
|
Bethel Advance And Quick Thin Products By Bethel Nutritional Consulting, Inc.: Recall - Undeclared Ingredients
|
8/6/2013
|
|
1:40 PM
|
FDA MedWatch RSS Feed
|
Sibutramine and Phenolphthalein may pose health threats or interact in life-threatening ways with other medications a consumer may be taking.
Full Article
|
|
Benztropine Mesylate Injection (Nexus Pharmaceuticals): Recall - Visible Particulate Matter
|
8/2/2013
|
|
7:45 PM
|
FDA MedWatch RSS Feed
|
Risk of thromboembolism, some life-threatening (such as pulmonary emboli), as well as other serious adverse events.
Full Article
|
|
Acetaminophen: Drug Safety Communication - Association with Risk of Serious Skin Reactions
|
8/1/2013
|
|
10:00 PM
|
FDA MedWatch RSS Feed
|
Events are rare but can be fatal.
Full Article
|
|
DePuy Orthopaedics-LPS Lower Extremity Dovetail Intercalary Component: Class 1 Recall - Potential for Fracture of Device
|
8/1/2013
|
|
9:30 PM
|
FDA MedWatch RSS Feed
|
Patients weighing more than 200 pounds and/or those with high levels of activity are at higher risk.
Full Article
|
|
Beacon Hill Medical Pharmacy/Rxtra Solutions: Recall - Lack of Sterility Assurance
|
8/1/2013
|
|
6:30 PM
|
FDA MedWatch RSS Feed
|
Sterile compounded products distributed nationwide
Full Article
|
|
Nova Max Glucose Test Strips: Recall - May Report False, Abnormally High Blood Glucose Result
|
7/29/2013
|
|
6:25 PM
|
FDA MedWatch RSS Feed
|
A false test result may lead to an insulin dosing error that could lead to a serious health risk requiring immediate medical attention.
Full Article
|
|
Mefloquine Hydrochloride: Drug Safety Communication - Label Changes Due To Risk of Serious Psychiatric and Nerve Side Effects
|
7/29/2013
|
|
3:10 PM
|
FDA MedWatch RSS Feed
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Effects from use may include dizziness, loss of balance, ringing in the ears, feeling anxious, mistrustful, or depressed, or having hallucinations.
Full Article
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GE Healthcare Nuclear Medicine Systems: Class I Recall - Serious Injuries or Deaths Could Occur
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7/29/2013
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4:00 AM
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FDA MedWatch RSS Feed
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Facilities are instructed to cease use of their Nuclear Medicine system until a GE Engineer is able to do a complete inspection of the system
Full Article
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Nizoral (ketoconazole): Drug Safety Communication - Potentially Fatal Liver Injury, Risk of Drug Interactions and Adrenal Gland Problems
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7/26/2013
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1:40 PM
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FDA MedWatch RSS Feed
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Nizoral tablets should be used only for the treatment of certain life-threatening mycoses when the potential benefits outweigh the risks, and alternative therapeutic options are not available or tolerated.
Full Article
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LeMaitre Vascular, Inc., Albograft Vascular Graft: Class I Recall - Blood Leak
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7/24/2013
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2:55 PM
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FDA MedWatch RSS Feed
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Use of this product may cause serious adverse health consequences, including death.
Full Article
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Diabetes Treatments: FDA Alerts of Illegal Sales - Undeclared Ingredients
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7/23/2013
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2:50 PM
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FDA MedWatch RSS Feed
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Some products may cause harm because they contain undeclared active drug ingredients or may not have been manufactured and handled according to FDA quality standards.
Full Article
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MedStream Programmable Infusion Pump: Class 1 Recall - Malfunction In The Fill Level Sensor
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7/23/2013
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2:15 PM
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FDA MedWatch RSS Feed
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The recommended pump refill date, computed by the Control Unit, may be incorrect.
Full Article
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Esbelin Silouttte Te and Esbelin Siloutte Vitamin Supplement: Recall - Undeclared Drug Ingredients
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7/23/2013
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1:30 PM
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FDA MedWatch RSS Feed
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These products pose a health threat to Consumers because Sibutramine is known to increase blood pressure and/or pulse rate and other related health risks.
Full Article
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Bryan Medical Tracoe Mini 3.0mm Tracheostomy Tube: Class 1 Recall - Mislabeled Packaging
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7/22/2013
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2:20 PM
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FDA MedWatch RSS Feed
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Using an oversized tracheostomy tube may cause permanent injury to the trachea.
Full Article
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Volcano Male Enhancement Liquid and Volcano Male Enhancement Capsules: Recall - Undeclared Drug Ingredients
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7/22/2013
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1:30 PM
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FDA MedWatch RSS Feed
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Lab tests revealed products contain PDE 5 inhibitors and other drug ingredients that can be life threatening.
Full Article
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Silver Sword and Clalis by hardmenstore.com: Recall - Undeclared Drug Ingredient
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7/15/2013
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7:20 PM
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FDA MedWatch RSS Feed
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Use of these products, which contain Sildenafil, can result in decreased blood pressure, light-headedness, and dizziness.
Full Article
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Medtronic MiniMed Paradigm Insulin Infusion Sets: Class 1 Recall - Potential for Over or Under Delivery of Insulin
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7/12/2013
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6:30 PM
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FDA MedWatch RSS Feed
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May result in hypoglycemia or hyperglycemia, which can be severe and lead to serious illness.
Full Article
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Verathon, Inc., GlideScope Video Laryngoscope (GVL) 3, 4, 5 and GlideScope (AVL) 2, 3, 4 and 5 Reusable Blades: Class I Recall - Risk of Blade Tip Breakage and Premature Failure
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7/10/2013
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7:40 PM
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FDA MedWatch RSS Feed
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Blade may break off in patients? mouth, where it may be swallowed or block the airway. This can lead to serious adverse health consequences, including hypoxemia (low blood oxygen), severe cuts to the airway leading to a significant loss of blood, and/or death.
Full Article
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Hubbard Feeds Inc. Announces Voluntary Recall in Indiana and Michigan Due to Potentially Elevated Calcium and Phosphorus in Medicated Poultry Feed
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7/5/2013
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6:11 PM
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FDA Pet Health RSS Feed
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MANKATO, MINNESOTA ? Hubbard Feeds Inc. announced today a voluntary recall of one lot of Hubbard Life Homestead FASTGROW AM.0.0125 NAB/NAB MEDICATED because of the elevated calcium and phosphorus levels which may be harmful to chickens and turkeys. Chickens and turkeys exposed to this product may exhibit decreased feed intake, decreased growth rate or death.
Full Article
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Estarylla (norgestimate and ethinyl estradiol): Recall - Report of Placebo Tablet Present in Row of Active Tablets
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7/5/2013
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2:30 PM
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FDA MedWatch RSS Feed
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Risk of pregnancy.
Full Article
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Olmesartan Medoxomil: Drug Safety Communication - Label Changes To Include Intestinal Problems (Sprue-Like Enteropathy)
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7/3/2013
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2:35 PM
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FDA MedWatch RSS Feed
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Enteropathy may develop months to years after starting olmesartan, and sometimes requires hospitalization.
Full Article
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RECOMBIVAX HB (Hepatitis B Vaccine (Recombinant)) Adult Formulation by Merck Sharp and Dohme Corp.: Recall - Potential For Cracked Vials
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7/3/2013
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12:55 PM
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FDA MedWatch RSS Feed
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If vial is cracked, integrity of the vial and sterility of any product remaining could not be assured.
Full Article
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Benztropine Mesylate Injection by Fresenius Kabi USA: Recall - Potential Presence Of Glass Particles
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7/2/2013
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1:45 PM
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FDA MedWatch RSS Feed
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If present, the administration of glass particulate poses a potential safety risk to patients.
Full Article
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Medtronic SynchroMed Implantable Infusion System Devices: Class 1 Recalls - Feed Through Failure, Failure of Priming Bolus, and Catheter Occlusion
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6/28/2013
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7:00 PM
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FDA MedWatch RSS Feed
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Medtronic SynchroMed II and SynchroMed EL Implantable Drug Infusion Pumps and Sutureless Connector Intrathecal Catheter Products Recalled.
Full Article
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JaDera and Xiyouji Qingzhi Dietary Supplements by Dolphin Intertrade Corp.: Recall - Undeclared Drug Ingredient
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6/28/2013
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5:30 PM
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FDA MedWatch RSS Feed
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Products have been found to contain undeclared Sibutramine, known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.
Full Article
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Hydroxyethyl Starch Solutions: FDA Safety Communication - Boxed Warning on Increased Mortality and Severe Renal Injury and Risk of Bleeding
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6/24/2013
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9:30 PM
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FDA MedWatch RSS Feed
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FDA has analyzed recent data indicating increased mortality and renal injury in critically ill adult patients who are treated with HES solutions. Posted 06/24/2013
Full Article
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Oxyphen, Phentalene, Phen FX, and Red Vipers by Beta Labs, LTD: Recall - Contains DMAA
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6/24/2013
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5:00 PM
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FDA MedWatch RSS Feed
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Ingestion of DMAA can elevate blood pressure and lead to cardiovascular problems.
Full Article
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Medtronic Xomed NIM Trivantage EMG Endotracheal Tube: Class I Recall - Cuff Leak or Cuff Deflation When Inflation Valve Cap Inappropriately Removed
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6/21/2013
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5:28 PM
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FDA MedWatch RSS Feed
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Physician may need to re-inflate or replace deflated tube to ensure the continued breathing support of the patient.
Full Article
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Respironics California, Inc. - Class 1 Recall: V60 Ventilators - Issue with software
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6/20/2013
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5:30 PM
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FDA MedWatch RSS Feed
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Ventilator support may be lost with potentially no audible alarm from the ventilator.
Full Article
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Enteric Coated Aspirin 81 mg Tablets by Advance Pharmaceutical Inc.: Recall of One Lot - May Contain Acetaminophen 500 mg Tablets
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6/19/2013
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9:50 PM
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FDA MedWatch RSS Feed
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Consumers may inadvertently take Acetaminophen 500 mg instead of Enteric Coated Aspirin 81 mg which may cause severe liver damage.
Full Article
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Natura Pet Issues Voluntary Recall of Specialized Dry Pet Foods Due to a Possible Health Risk
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6/18/2013
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5:58 PM
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FDA Pet Health RSS Feed
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Natura Pet Products is voluntarily recalling specific lots of dry pet food because it has the potential to be contaminated with Salmonella. Salmonella can affect animals eating the products and there is risk to humans from handling contaminated pet products, especially if they have not thoroughly washed their hands after having contact with the products or any surfaces exposed to these products.
Full Article
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Zyprexa Relprevv (Olanzapine Pamoate): Drug Safety Communication - FDA Investigating Two Deaths Following Injection
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6/18/2013
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4:00 PM
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FDA MedWatch RSS Feed
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Two patients died 3-4 days after receiving an appropriate dose of the drug. Posted 06/18/2013
Full Article
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Endologix, Inc. AFX Introducer System: Class 1 Recall - Reports Of Dilator Breaking During Procedures
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6/18/2013
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2:30 PM
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FDA MedWatch RSS Feed
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Use of this recalled product may cause serious adverse health consequences, including death. Posted 06/18/2013
Full Article
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Cybersecurity for Medical Devices and Hospital Networks: FDA Safety Communication
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6/17/2013
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6:27 PM
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FDA MedWatch RSS Feed
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Many medical devices contain configurable embedded computer systems that can be vulnerable to cybersecurity breaches.
Full Article
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May 2013 - Drug Safety Labeling Changes
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6/13/2013
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10:15 PM
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FDA MedWatch RSS Feed
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MedWatch May 2013 drug safety labeling changes
Full Article
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Hartz Mountain Corporation is Voluntarily Recalling One Specific Lot of 1.2 oz. Size of Wardley Betta Fish Food Due to Possible Health Risk
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6/13/2013
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3:31 PM
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FDA Pet Health RSS Feed
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SECAUCUS, N.J., /PRNewswire/ - The Hartz Mountain Corporation, located in Secaucus, N.J. is voluntarily recalling one specific lot of Wardley Betta Fish Food 1.2 oz. size due to concerns that one or more containers within the lot may have been potentially contaminated with Salmonella. Hartz is fully cooperating with the US Food and Drug Administration in this voluntary recall.
Full Article
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Warfarin 2 mg Tablets by Zydus Pharmaceuticals USA Inc.: Recall - Due to Oversized Tablets
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6/12/2013
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10:23 PM
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FDA MedWatch RSS Feed
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Ingestion of a greater than intended dose of Warfarin, could lead to an increased pharmacological effect of warfarin. As a result, patients would be more likely to develop bleeding and in some patients that bleeding into a critical organ could be fatal.
Full Article
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Symbios GOPump and GOBlock Kits: Class 1 Recall - Potential for Excessive High Flow Rates
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6/12/2013
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9:30 PM
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FDA MedWatch RSS Feed
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Excessive high flow rates, presents a risk of patient toxicity and serious injury (e.g., seizure, dysrhythmia, death) due to the rapid influx of medication particularly in patients with low body mass or advanced age.
Full Article
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Bethel Nutritional Consulting, Inc. Bethel 30: Recall: Undeclared Drug Ingredient.
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6/11/2013
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8:00 PM
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FDA MedWatch RSS Feed
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Testing revealed the product contains Sibutramine, which may increase blood pressure or interact, in life-threatening ways, with other medications a consumer may be taking.
Full Article
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Vecuronium Bromide For Injection by Sagent Pharmaceuticals, Inc.: Recall - Elevated Impurity Result Detected
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6/10/2013
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8:00 PM
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FDA MedWatch RSS Feed
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UPDATED 06/13/2013. Recall expanded to all lots. The elevated impurity result has the potential to result in prolonged neuromuscular blockade for critically ill patients with renal failure.
Full Article
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Main Street Family Pharmacy in Tennessee: FDA Alerts Health Care Providers of Adverse Reactions Associated with Steroid Injections
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6/7/2013
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3:25 PM
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FDA MedWatch RSS Feed
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UPDATED 06/07/2013. FDA identified bacterial and fungal growth in samples from two unopened vials of preservative-free (PF) methylprednisolone acetate (MPA) 80 mg/mL, 10mL vials. Originally posted 05/24/2013
Full Article
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Nephron Pharmaceuticals Corp. EZ Breathe Atomizer: Class 1 Recall - Washer Could Become Dislodged
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6/3/2013
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7:05 PM
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FDA MedWatch RSS Feed
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Users may accidentally swallow or choke on dislodged washer, which can lead to serious adverse health consequences or death.
Full Article
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Olympia Pharmacy Sterile Compounded Products: Recall - Concerns About Sterility Assurance
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5/30/2013
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7:40 PM
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FDA MedWatch RSS Feed
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Use of a compromised product may put patients at risk for serious and possible life threatening infections.
Full Article
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Magnesium Sulfate: Drug Safety Communication - Recommendation Against Prolonged Use in Pre-term Labor
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5/30/2013
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7:00 PM
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FDA MedWatch RSS Feed
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Prolonged use to stop pre-term labor may cause bone changes in exposed babies.
Full Article
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Magnesium Sulfate Injection by Fresenius Kabi USA: Recall - Glass Particles in Vials
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5/29/2013
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4:55 PM
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FDA MedWatch RSS Feed
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Administration of glass particulate can lead to serious adverse events, including life-threatening thromboembolism.
Full Article
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Cook Medical, Inc Zilver PTX Drug-Eluting Peripheral Stent: Class 1 Recall - Complaints of Delivery System Tip Separation
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5/24/2013
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3:30 PM
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FDA MedWatch RSS Feed
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Inner delivery catheter breakage can lead to vascular occlusion, thrombosis, amputation, possible cardiac arrest, or death.
Full Article
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Abbott Diabetes Care: Class 1 Recall - FreeStyle InsuLinx Blood Glucose Meters - Risk of Incorrect Test Result
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5/20/2013
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6:00 PM
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FDA MedWatch RSS Feed
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Incorrect test results at extremely high blood glucose levels.
Full Article
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All Sterile Drug Products Made and Distributed By NuVision Pharmacy Dallas Facility: Recall - Lack Of Sterility Assurance
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5/18/2013
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7:51 PM
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FDA MedWatch RSS Feed
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If a drug product marketed as sterile has microbial contamination, patient is at risk of serious infection.
Full Article
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Compounded Prescription Therapies By Pentec Health Inc.: Recall - Lack Of Sterility Assurance
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5/17/2013
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7:55 PM
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FDA MedWatch RSS Feed
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Patients are at increased risk of infection in the event a sterile product is compromised.
Full Article
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Rural King Recalls Deer Corn Because of Possible Health Risk
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5/17/2013
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1:41 PM
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FDA Pet Health RSS Feed
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Rural King Distributing of Mattoon, IL is recalling 205 tons of Deer Corn, because it has the potential to be contaminated with aflatoxin. Aflatoxin is a naturally occurring mold by-product.
Full Article
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Zolpidem Containing Products: Drug Safety Communication - FDA Requires Lower Recommended Doses
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5/14/2013
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2:30 PM
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FDA MedWatch RSS Feed
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UPDATED 05/14/2013. FDA has approved label changes specifying new dosing recommendations for zolpidem products.
Full Article
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Atriphen dietary supplement (Xymogen brand): Recall - Potential Allergic Reaction Due to Milk and Soy
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5/9/2013
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8:00 PM
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FDA MedWatch RSS Feed
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Risk of serious or life-threatening allergic reaction.
Full Article
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SexVoltz, Velextra, and Amerect by Beomonstar Products: Recall - Undeclared Drug Ingredient
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5/8/2013
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1:30 PM
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FDA MedWatch RSS Feed
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Undeclared tadalafil may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels.
Full Article
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Bullet Proof: Public Notification - Undeclared Drug Ingredient
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5/7/2013
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9:30 PM
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FDA MedWatch RSS Feed
|
Testing revealed the product contains tadalafil, which may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels.
Full Article
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Lightning Rod Capsules: Recall - Undeclared Drug Ingredient
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5/7/2013
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9:15 PM
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FDA MedWatch RSS Feed
|
Testing revealed the product contains an analogue of sildenafil, which may interact with nitrates found in prescription drugs such as nitroglycerin, and lower blood pressure to dangerous levels.
Full Article
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Maquet SERVO-i Ventilator Battery Module: Class 1 Recall - Battery Run Time Shorter Than Expected
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5/7/2013
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8:45 PM
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FDA MedWatch RSS Feed
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May result in unexpected ventilator shut downs, which can result in serious adverse health consequences, including death.
Full Article
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Medtronic: Class 1 Recall - Medtronic Deep Brain Stimulation Lead Kit and Activa Dystonia HDE Kit
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5/7/2013
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6:30 PM
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FDA MedWatch RSS Feed
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Use of lead cap may cause lead damage. Lead replacement may be required or optimal therapy may not be provided.
Full Article
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Diamond Pet Foods Announces Recall of Premium Edge Adult Cat and Premium Edge Hairball Cat Food
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12/1/2009
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3:11 PM
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FDA Pet Health RSS Feed
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On September 23, Diamond Pet Foods issued a voluntary recall for Premium Edge Finicky Adult Cat and Premium Edge Hairball cat because they have the potential to produce Thiamine Deficiency. Today’s announcement provides additional information from the company’s posted announcement of September 23 when the initial recall information was provided.
Full Article
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