Injections Recalled Over Sterility Concerns

A lack of sterility assurance has prompted Drug Depot Inc, doing business as APS Pharmacy, to recall more than 7000 vials of gonadorelin, according to the April 6, 2022, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects the following products, which were distributed throughout the United States, including Puerto Rico:

• gonadorelin (5 mL) .2 mg/mL injectable, packaged in a multidose 10-mL vial, formula ID132227, from lots 745708 (beyond-use date [BUD] 6/21/2022), 753364 (BUD 7/27/22), 752508 (BUD 7/24/22), 750313 (BUD 7/16/22), 753020 (BUD 7/26/22), 747712 (BUD 7/4/22), 747974 (BUD 7/5/22), 754802 (BUD 8/3/22), 751158 (BUD 7/19/22), 756837 (BUD 8/16/22), 748939 (BUD 7/10/22), 750842 (BUD 7/18/22), 755742 (BUD 8/8/22), 758691 (BUD 8/28/22), 758432 (BUD 8/27/22), 758975 (BUD 8/29/22), and 756643 (BUD 8/15/22); and
• gonadorelin (4 mL) .2 mg/mL injectable, packaged in a multidose 10-mL vial, formula ID136345, from lots 749842 (BUD 7/13/22), 749568 (BUD 7/12/22), 752053 (BUD 7/23/22), 752817 (BUD 7/25/22), 757404 (BUD 8/21/22), 757915 (BUD 8/23/22), 757321 (BUD 8/20/22), and 753718 (BUD 7/30/22).

Drug Depot voluntarily initiated the recall March 23, 2022. On March 29, 2022, the FDA designated the recall Class II. Drugs affected by Class II recalls may cause temporary or medically reversible adverse health consequences if used. While remote, a possibility of serious harm also exists.

Gonadorelin is a gonadotropin-releasing hormone that causes the pituitary gland to release other hormones, such as luteinizing hormone and follicle-stimulating hormone.