Accord Healthcare, Inc.: Glimepiride Tablets USP, 2 mg, Rx Only, Packaged in: a) 100 Tablets NDC 16729-002-01 UPC 3 16729 00201 1; b) 500 Tablets NDC 16729-002-16 UPC 3 16729 00216 5; Manufactured for

Hazard

CGMP Deviations: recalling drug products following an FDA inspection.

Details from the source

Reason for recall: CGMP Deviations: recalling drug products following an FDA inspection. Distribution: United States including Puerto Rico and Canada Quantity: 992,622 bottles Lot/code info: Batches: a) R2000184, Exp. Date 4/30/2023, R2000183 Exp. Date 4/30/2023, P2002969 Exp. Date 5/31/2023, P2002970 Exp. Date 5/31/2023, P2005346 Exp. Date 8/31/2023, P2005847 Exp. Date 10/31/2023, P2006133 Exp. Date 10/31/2023, P2100682 Exp. Date 1/31/2024, P2102065 Exp. Date 3/31/2024, P2102067 Exp. Date 3/31/2024, P2102068 Exp. Date 3/31/2024, P2102070 Exp. Date 3/31/2024, R2100659 Exp. Date 5/31/2024, R2100660 Exp. Date 5/31/2024, P2103898 Exp. Date 6/30/2024, P2106000 Exp. Date 7/31/2024, R2101442 Exp. Date 9/30/2024, P2201160 Exp. Date 1/31/2025, P2200695 Exp. Date 1/31/2025, P2200694 Exp. Date 1/31/2025; b) P2005530, Exp. Date 9/30/2023, P2005531 Exp. Date 9/30/2023, P2005532 Exp. Date 9/30/2023, P2005533 Exp. Date 9/30/2023, P2005846 Exp. Date 10/31/2023, P2006594 Exp. Date 11/30/2023, P2100602 Exp. Date 1/31/2024, P2100603 Exp. Date 1/31/2024, P2100604 Exp. Date 1/31/2024, P2100605 Exp. Date 1/31/2024, P2101571 Exp. Date 2/29/2024, P2101572 Exp. Date 2/29/2024, P2102046 Exp. Date 3/31/2024, P2102047 Exp. Date 3/31/2024, P2102049 Exp. Date 3/31/2024, P2102050 Exp. Date 3/31/2024, P2102051 Exp. Date 3/31/2024, P2102052 Exp. Date 3/31/2024, P2103017 Exp. Date 4/30/2024, P2103018 Exp. Date 4/30/2024, P2103900 Exp. Date 6/30/2024, P2104436 Exp. Date 6/30/2024, P2105399 Exp. Date 7/31/2024, P2105400 Exp. Date 7/31/2024, P2106257 Exp. Date 9/30/2024, P2106258 Exp. Date 9/30/2024, P2106259 Exp. Date 9/30/2024, R2101443 Exp. Date 9/30/2024, R2101445 Exp. Date 9/30/2024, R2101444

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.