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. A few products were shipped to Hawaii, New Mexico, and Michigan.
All recalled products have a label that includes Reliable Drug name or Reliable Compounding Pharmacy and expiration date. If unsure, Customers can call the pharmacy to determine the expiration date. This recall impacts all compounded products distributed between 03/24/2015 and 03/24/2016.
The recall was issued after a series of onsite inspections by the FDA. Out of an abundance of caution, Reliable Drug is voluntarily recalling all compounded product within expiry.
Customers that have recalled product should immediately stop using it and contact the pharmacy to arrange for the return of unused product. Customers should contact their physician or health care provider if they have experienced any problems that may be related to taking or using these products.
Customers with questions regarding this recall can contact Reliable Drug Pharmacy by phone (415) 664-8800 Monday through Friday 10 am - 6:30 pm and Saturday 9 am - 12:30 pm, or email its media representative.
Adverse reactions or quality problems experiences with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
- For reporting animal adverse drug events: http://www.fda.gov/AnimalVeterinary/SafetyHealth/ReportaProblem/ucm055305.htm
Reliable Drug Pharmacy deeply regrets any disruption that this voluntary recall and temporary suspension of compounding services have on its Customers, but notes that safety and quality are its primary concerns.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration and California State Board of Pharmacy.
Original Press Release
###
