Accord Healthcare, Inc.: Aripiprazole Tablets, USP 5 mg Rx Only, Packaged as a) 30-count bottle, NDC 16729-279-10, UPC 3 16729 27910 9; b) 100-count bottle, NDC 16729-279-01, UPC 3 16729 27901 7; Manu

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: 1,109,904 bottles Lot/code info: Batches: a) P2004259, P2004260, P2004261, Exp. Date 7/31/2023; P2006799, P2101391, Exp. Date 11/30/2023; P2100826, Exp. Date 1/31/2024; P2101320, Exp. Date 2/28/2024; P2102510, P2102409, P2102407, Exp. Date 3/31/2024; P2102410, Exp. Date 3/31/2024; P2105251, P2105252, P2105253, Exp. Date 7/31/2024; P2107404, P2107029, Exp. Date 10/31/2024; P2200260, P2200265, Exp. Date 12/31/2024; P2202067, P2202068, Exp. Date 3/31/2025; P2204239, Exp. Date 7/31/2025; b) P2006800 Exp. Date 11/30/2023; P2102141, Exp. Date 3/31/2024; P2104085, Exp. Date 6/30/2024; P2107031, P2107466, Exp. Date 10/31/2024;

Source

Official record: FDA (Drug enforcement) ↗

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