AUDIENCE: Patient, Consumer, Health Professional, Risk Manager, Veterinary Medicine

ISSUE: FDA is alerting patients and health care professionals not to use certain compounded products produced and distributed by Drug Depot, LLC, doing business as APS Pharmacy intended to be sterile, due to lack of sterility assurance. Administration of non-sterile products intended to be sterile may result in serious and potentially life-threatening infections or death.

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.

Since the company initiated the recall and began contacting patients using the recalled drugs, FDA has received adverse event reports from APS Pharmacy regarding injection site reactions, such as pain, redness, swelling and abscesses requiring medical treatment; and systemic reactions, which include fever, chills, and rash. To date, FDA has received two reports of adverse events occurring in animals following use of the recalled animal ophthalmic products.

For more information about this alert, click on the red button "Read Alert" below.

BACKGROUND: APS Pharmacy initiated the nationwide recall via a recall letter dated March 15, 2022. The company has sent recall letters to patients and animal owners who received the recalled drugs, and they are contacting customers via telephone calls and emails as part of their recall strategy.

RECOMMENDATIONS: 

• 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.
• 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 and animal owners/caretakers who have received these recalled drugs  from APS Pharmacy should contact their health care professional/veterinarian as appropriate.
• FDA urges health care professionals and consumers who obtained recalled drugs to make alternative arrangements to obtain medications from sources that meet applicable quality standards.

Health 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.
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.