Accord Healthcare, Inc.: Rosuvastatin Tablets, USP, 10 mg*, Rx Only, Packaged as: a) 90-count bottle, NDC 16729-285-15, UPC 3 16729 28515 5; b) 1,000-count bottle NDC 16729-285-17, UPC 3 16729 28517 9

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: 56,862 bottles Lot/code info: Batches: a) P2006824, Exp. Date 11/30/2023; P2102223, Exp. Date 3/31/2024; b) P2004949, Exp. Date 8/31/2023; P2004948, Exp. Date 8/31/2023; P2004950, Exp. Date 8/31/2023; P2004953, Exp. Date 8/31/2023; P2004954, Exp. Date 8/31/2023; P2004956, Exp. Date 8/31/2023; P2004955, Exp. Date 8/31/2023; P2004957, Exp. Date 8/31/2023; P2004958, Exp. Date 8/31/2023; P2004959, Exp. Date 8/31/2023; P2005252, Exp. Date 9/30/2023; P2006607, Exp. Date 11/30/2023; P2101368, Exp. Date 2/29/2024; P2101777, Exp. Date 2/29/2024; P2102224, Exp. Date 3/31/2024; P2104397, Exp. Date 6/30/2024; P2104395, Exp. Date 6/30/2024; P2104398, Exp. Date 6/30/2024; P2105120, Exp. Date 7/31/2024; P2204835, Exp. Date 7/31/2025; P2204834, Exp. Date 7/31/2025; P2204837, Exp. Date 7/31/2025; P2205832, Exp. Date 9/30/2025; P2205833, Exp. Date 9/30/2025;

Source

Official record: FDA (Drug enforcement) ↗

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