Diabetes Medication Recalled

TMC Acquisition, which does business as Tailor Made Compounding, is recalling numerous batches of semaglutide/cyanocobalamin over sterility concerns, according to the July 20, 2022, US Food and Drug Administration (FDA) Enforcement Report.

The Tailor Made Compounding recall affects the following semaglutide/cyanocobalamin products, which were distributed throughout the United States and in Puerto Rico:

• semaglutide/cyanocobalamin, 2 mg/.4 mg/mL, in 1-mL vials from batches 12032123A2 (Exp. 3/3/22), 12102101A2 (Exp. 3/10/22), 12202105A2 (Exp. 3/20/22), 12292106A2 (Exp. 3/29/22), 01062218B (Exp. 4/6/22), 01192228A2, (Exp. 4/19/22), 01312214A2 (Exp. 5/1/22), 02012211A1 (Exp. 5/2/22), 02182201A1 and 02182203A1 (Exp. 5/19/22), 02242205A1 and 02242206A1 (Exp. 5/25/22), 03072209A1 (Exp. 6/5/22), and 03092203A1 and 03092206A1 (Exp. 6/7022); and
• semaglutide/cyanocobalamin, 5 mg/.2 mg/mL, in 2-mL vials from batches 12092115A2 (Exp. 3/9/22), 12162116A2 (Exp. 3/16/22), 12212106A2 (Exp. 3/21/22), 01062219B (Exp. 4/6/22), 01072205A1 and 01072208A1 (Exp. 4/7/22), 01102203A1 (Exp. 4/10/22), 01132207A1 (Exp. 4/13/22), 01192216A1 (Exp. 4/19/22), 01202204A2 (Exp. 4/20/22), 01272223A2 (Exp. 4/27/22), 01312219A2 (Exp. 5/1/22), 02032204A2 (Exp. 5/4/22), 02072203A1 (Exp. 5/8/22), 02182216A1 and 02182224A1 (Exp. 5/19/22), 02232202A1 and 02232210A1 (Exp. 5/24/22), 02242202A1, 02242203A1, 02242235A1, and 02242238A1 (Exp. 5/25/22), 03072217A1 and 03072223A1 (Exp. 6/5/22), 03082223A1 and 03082229A1 (Exp. 6/6/22), and 03092207A1 and 03092219A1 (Exp. 6/7/22).

TMC Acquisition voluntarily initiated the recalls March 7, 2022. On July 14, 2022, the FDA designated them Class II. The recall designation signals that use of the product could cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists.

Semaglutide is a prescription medication used to manage type 2 diabetes. Cyanocobalamin is a form of vitamin B₁₂.