Diabetes Drug Recalled

Amerisource Health Services is recalling nearly 300,000 bottles of glimepiride tablets manufactured for BluePoint Laboratories after an inspection of the manufacturing facility found deviations from Current Good Manufacturing Practices, according to the May 31, 2023, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects the following products, which were manufactured by Intas Pharmaceuticals Limited, Pharmez, Ahmedabad, India, and distributed throughout the United States:

• glimepiride tablets, 1 mg, in 100-count bottles (NDC 68001-177-00), from lots P2002616 (Exp 4/30/23), P2006509 (Exp 11/30/23), P2103572 (Exp 4/30/24), P2106811 (Exp 9/30/24), and R2200578 (Exp 4/30/25);
• glimepiride tablets, 1 mg, in 500-count bottles (NDC 68001-177-03), from lots P2100095 (Exp 11/30/23), P2100624 (Exp 1/31/24), P2101780 (Exp 2/29/24), P2107383 (Exp 9/30/24), P2201505 (Exp 2/28/25), and R2201109 (Exp 6/30/25);
• glimepiride tablets, 2 mg, in 100-count bottles (NDC 68001-178-00), from lots P2003493 (Exp 5/31/23), P2100120 (Exp 11/30/23), P2100683 (Exp 1/31/24), P2106002 (Exp 7/31/24), R2200148 (Exp 12/31/24), and R2201125 (Exp 6/30/25);
• glimepiride tablets, 2 mg, in 500-count bottles (NDC 68001-178-03), from lots P2003403 (Exp 5/31/23), P2005800 (Exp 9/30/23), P2101156 (Exp 1/31/24), P2105401 (Exp 7/31/24), R2200083 (Exp 12/31/24), and R2201004 (Exp 7/31/25);
• glimepiride tablets, 4 mg, in 100-count bottles (NDC 68001-179-00), from lots P2003403 (Exp 5/31/23), P2006593 (Exp 11/30/23), P2101152 (Exp 1/31/24), P2105014 (Exp 6/30/24), R2101440 (Exp 9/30/24), P2200774 (Exp 1/31/25), and R2200664 (Exp 4/30/25); and
• glimepiride tablets, 4 mg, in 500-count bottles (NDC 68001-179-03), from lots P2100705 (Exp 1/31/24), P2104672 (Exp 6/30/24), R2101435 (Exp 9/30/24), R2200102 (Exp 12/31/24), R2200577 (Exp 4/30/25), P2205870 (Exp 8/31/25), and P2100121 (Exp 11/30/23).

Amerisource Health Services voluntarily initiated the recall March 17, 2023. On May 19, 2023, 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.

Glimepiride is a prescription medication indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.