Safety

Compounded Products by Reliable Drug Pharmacy: Recall - Potential for Mislabeling and Lack of Quality Assurance

UPDATED 03/31/2016. Link to FDA CDER Statement added, containing additional details on the recall, including the FDA investigation of Reliable Drug Pharmacy.

[Posted 03/28/2016]

AUDIENCE: Pharmacy

ISSUE: Reliable Drug Pharmacy is 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.

The recall was issued after a series of onsite inspections by the FDA.

BACKGROUND: All recalled products have a label that includes Reliable Drug name and expiration date. If unsure, customers can call the pharmacy to determine the expiration date. This recall impacts all compounded products distributed between 09/24/2015 and 03/24/2016.

RECOMMENDATION: Customers that have recalled product should immediately stop using it and should contact Reliable Drug 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.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report
  • Download form 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


[03/30/2016 - Statement - FDA]
[03/25/2016 - Press Release - Reliable Drug Pharmacy]
 

Page Last Updated: 03/31/2016
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