Accord Healthcare, Inc.: Glimepiride Tablets USP, 4 mg, Rx Only, Packaged in: a) 100-count bottle NDC 16729-003-01 UPC 3 16729 00301 8; b) 500-count NDC 16729-003-16 UPC 3 16729 00316 2; Manufactured

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: 1,158,839 bottles Lot/code info: Batches: a) P2001868, Exp. Date 3/31/2023, P2001869 Exp. Date 3/31/2023, P2002810 Exp. Date 5/31/2023, P2005473 Exp. Date 8/31/2023, P2005552 Exp. Date 9/30/2023, P2101986 Exp. Date 3/31/2024, P2101989 Exp. Date 3/31/2024, P2101988 Exp. Date 3/31/2024, P2101991 Exp. Date 3/31/2024, P2101992 Exp. Date 3/31/2024, R2100736 Exp. Date 6/30/2024, R2100737 Exp. Date 6/30/2024, P2105281 Exp. Date 7/31/2024, R2101441 Exp. Date 9/30/2024, R2101454 Exp. Date 10/31/2024, R2101455 Exp. Date 10/31/2024, R2101468 Exp. Date 10/31/2024, R2101469 Exp. Date 10/31/2024, R2200096 Exp. Date 12/31/2024; b)P2005550, Exp. Date 9/30/2023, P2005549 Exp. Date 9/30/2023, P2005551 Exp. Date 9/30/2023, P2005812 Exp. Date 10/31/2023, P2005813 Exp. Date 10/31/2023, P2005970 Exp. Date 10/31/2023, P2005971 Exp. Date 10/31/2023, P2005974 Exp. Date 10/31/2023, P2005814 Exp. Date 10/31/2023, P2005972 Exp. Date 10/31/2023, P2005973 Exp. Date 10/31/2023, P2005998 Exp. Date 10/31/2023, P2005999 Exp. Date 10/31/2023, P2006001 Exp. Date 10/31/2023, P2005997 Exp. Date 10/31/2023, P2006000 Exp. Date 10/31/2023, P2100701 Exp. Date 1/31/2024, P2100702 Exp. Date 1/31/2024, P2100703 Exp. Date 1/31/2024, P2100704 Exp. Date 1/31/2024, P2102512 Exp. Date 3/31/2024, P2101993 Exp. Date 3/31/2024, P2101994 Exp. Date 3/31/2024, P2102951 Exp. Date 4/30/2024, P2102952 Exp. Date 4/30/2024, P2102953 Exp. Date 4/30/2024, P2102954 Exp. Date 4/30/2024, R2100739 Exp. Date 6/30/2024, R2100738 Exp. Date 6/30/2024, R2100740 Exp. Date 6/30/20

Source

Official record: FDA (Drug enforcement) ↗

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