Recall -- State / Local Press Release
FDA posts press releases and other notices of recalls and safety alerts from states as a service to consumers, the media, and other interested parties. FDA is not responsible for the content of these notices.
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.
Contact:
Consumer:
919-246-1050
FOR IMMEDIATE RELEASE — April 1, 2015 — Fayetteville, NC — 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. This recall order is due the pharmacy’s inability to ensure sterility, stability, and potency for these products. In addition to ordering a recall, the Board of Pharmacy ordered the Prescription Center closed. The Board has not received a complaint of an injury caused by any recalled product, but use of compounded products lacking assurance of sterility, stability, and potency places patients at risk.
Prescription Center distributed the recalled compounded products in all fifty (50) states, as well as Canada, between September 10, 2014, and March 10, 2015. Health care providers and patients should stop using all compounded products distributed by Prescription Center immediately and dispose of the products according to state and/or local government guidelines.
Questions concerning disposal should be directed to the board of pharmacy in the patient’s or health care provider’s home state.
The Food and Drug Administration’s website also provided recommendations on safe disposal: http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/EnsuringSafeUseo
fMedicine/SafeDisposalofMedicines/ucm186187.htm#MEDICINES
Patients or health care providers with questions regarding this recall may contact the North Carolina Board of Pharmacy at 919.246.1050. Patients who have concerns regarding use or consumption of any recalled products should contact their health care provider.
Suspected adverse reactions or quality problems experienced as a result of using recalled product may be reported to the North Carolina Board of Pharmacy and the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Online: complaints@ncbop.org (North Carolina Board of Pharmacy);
www.fda.gov/medwatch/report.htm1 (FDA)
Regular Mail:
6015 Farrington Road, Suite 201, Chapel Hill, NC 27517 (North Carolina Board of Pharmacy)
Use postage-paid, pre-addressed Form FDA 3500 available at:
www.fda.gov/MedWatch/getforms.htm2. Mail to address on the pre-addressed form (FDA)
Fax: 919-246-1056 (North Carolina Board of Pharmacy); 1-800-FDA-0178 (FDA)
###
FDA News Release