Accord Healthcare, Inc.: Tadalafil Tablets, USP 10 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-371-10, UPC 3 16729 37110 0; b) 500-count bottle NDC 16729-371-16, UPC 3 16729 37116 2; Manufac

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: 176,323 bottles Lot/code info: Batches: a) P2002525, Exp. Date 4/30/2023; P2004442, Exp. Date 7/31/2023; P2005014, Exp. Date 8/31/2023; P2005015, Exp. Date 8/31/2023; P2005016, Exp. Date 8/31/2023; P2005825, Exp. Date 10/31/2023; P2005824, Exp. Date 10/31/2023; P2005826, Exp. Date 10/31/2023; P2100368, Exp. Date 12/31/2023; P2100444, Exp. Date 12/31/2023; P2101262, Exp. Date 2/29/2024; P2101263, Exp. Date 2/29/2024; P2200813, Exp. Date 1/31/2025; P2200814, Exp. Date 1/31/2025; b) P2002526, Exp. Date 4/30/2023; P2003781, Exp. Date 6/30/2023; P2003782, Exp. Date 6/30/2023; P2003783, Exp. Date 6/30/2023; P2004440, Exp. Date 7/31/2023; P2004441, Exp. Date 7/31/2023; P2005820, Exp. Date 10/31/2023; P2005821, Exp. Date 10/31/2023; P2005823, Exp. Date 10/31/2023; P2100077, Exp. Date 12/31/2023; P2100076, Exp. Date 12/31/2023; P2100078, Exp. Date 12/31/2023; P2100079, Exp. Date 12/31/2023; P2100080, Exp. Date 12/31/2023; P2100366, Exp. Date 12/31/2023; P2100442, Exp. Date 12/31/2023; P2100443, Exp. Date 12/31/2023; P2101265, Exp. Date 2/29/2024; P2101264, Exp. Date 2/29/2024; P2101718, Exp. Date 2/29/2024; P2108091, Exp. Date 11/30/2024; P2108092, Exp. Date 11/30/2024; P2108093, Exp. Date 11/30/2024; P2203589, Exp. Date 6/30/2025; P2203588, Exp. Date 6/30/2025; P2205379, Exp. Date 8/31/2025;

Source

Official record: FDA (Drug enforcement) ↗

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