Compound drugs for humans and pets recalled because they may not be sterile
The United States Food and Drug Administration has issued an alert to customers of Drug Depot, which does business as APS Pharmacy of Palm Harbor, Florida.
Drug Depot has voluntarily recalled certain compound drugs “due to lack of sterility assurance”.
The FDA said that since the company issued a recall and began contacting patients, the “FDA has received adverse event reports from APS Pharmacy regarding injection site reactions, such as pain, redness , swelling and abscess requiring medical treatment; and systemic reactions, which include fever, chills, and rash.
To date, the FDA has received two reports of adverse events in animals resulting from the use of the recalled animal ophthalmic products.
Using an unsterile drug, the FDA said, “can lead to serious and life-threatening infections.”
The recalled drugs were intended for humans and pets.
Drugs recalled for humans include:
- Gonadorelin acetate
- Testosterone Cypionate in Grapeseed Oil
- Testosterone Cypionate/Anastrozole in Grapeseed Oil
- Testosterone Cypionate/DHEA in Grapeseed Oil
The recalled medications for animals are:
All recalled drugs were prepared between December 21, 2021 and March 7, 2022. The recalled drugs, lot numbers and do not use dates after that can be found here.
Healthcare professionals and consumers should report adverse events or side effects associated with the use of APS Pharmacy products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report online at www.fda.gov/medwatch/report.htm; or
- Download the form or call 800-332-1088 to request a report form, then complete and return it to the address listed on the form, or submit it by fax to 800-FDA-0178.
Veterinarians and pet owners/custodians should report adverse events or side effects in animals related to the use of these products to the FDA’s Center for Veterinary Medicine.
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