FDA Update: Possible Sterility Issues for Human/Animal Drug Cause the FDA to Alert Customers to Voluntary Recall

More and more drugs are being compounded by compound pharmacies. The FDA does regulate compound pharmacies and periodically these companies and drugs run into a problem that require a recall.

FDA is alerting patients, health care professionals, veterinarians, and animal owners/caretakers about a voluntary recall by Drug Depot, LLC, doing business as APS Pharmacy, of certain unexpired compounded drugs due to a lack of sterility assurance. Administration of a non-sterile drug intended to be sterile may result in serious and potentially life-threatening infections.

APS Pharmacy, located in Palm Harbor, Florida, which compounds drugs intended for human use and drugs intended for animal (veterinary) use, initiated the voluntary nationwide recall via a recall letter dated March 15, 2022. The company has sent recall letters to all patients and animal owners who received the recalled drugs, and they are contacting all customers via telephone calls and emails as part of their recall strategy.

The recalled drugs include “gonadorelin acetate,” “testosterone cypionate in grapeseed oil,” “testosterone cypionate/anastrozole in grapeseed oil,” “testosterone cypionate/DHEA in grapeseed oil,” and “testosterone cypionate/propionate in sesame seed oil” for human use, and “cyclosporin” and “tacrolimus” for animal ophthalmic use. These products were compounded between December 21, 2021, and March 7, 2022. The recalled drugs, lot numbers, and do-not-use beyond date – the date when the compounded drug should no longer be used – are listed here.

Patients should not use, and animal owners/caretakers should not administer, the recalled drugs from APS Pharmacy. If they are not sure if they have a recalled drug, they should contact APS pharmacy to confirm. Patients who have received these recalled drugs from APS Pharmacy should contact their health care professional. Animal owners/caretakers should contact their veterinarian as appropriate.

Health care professionals and veterinarians should immediately check their medical supplies, quarantine any recalled drugs from APS Pharmacy, and not administer or provide them to patients or animals.

mdi will monitor the FDA’s recommendations and warnings regarding this drug recall and warning. For more information on compound pharmacies or on this FDA policy please contact mdi at: [email protected] and ref: Drug Depot, LLC, doing business as APS Pharmacy compounded drug recall.