Accord Healthcare, Inc.: Rosuvastatin Tablets, USP, 5 mg*, Rx Only, Packaged as: a) 90-count bottle, NDC 16729-284-15, UPC 3 16729 28415 8; b) 1,000-count bottle, NDC 16729-284-17, UPC 3 16729 28417 2

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: 63,247 bottles Lot/code info: Batches: a) P2101063, Exp. Date 1/31/2024; P2101707, Exp. Date 2/29/2024; P2203913 Exp. Date 6/30/2025; b) P2101064, Exp. Date 1/31/2024; P2101539, Exp. Date 1/31/2024; P2101709, Exp. Date 2/29/2024; P2102138, Exp. Date 2/29/2024; P2103186, Exp. Date 5/31/2024; P2104430, Exp. Date 6/30/2024; P2104703, Exp. Date 7/31/2024; P2104704, Exp. Date 7/31/2024; P2104705, Exp. Date 7/31/2024; P2104702, Exp. Date 7/31/2024; P2107176, Exp. Date 10/31/2024; P2107177, Exp. Date 10/31/2024; P2107178, Exp. Date 10/31/2024; P2107181, Exp. Date 10/31/2024; P2203915, Exp. Date 6/30/2025; P2203914, Exp. Date 6/30/2025; P2204998, Exp. Date 8/31/2025; P2204999, Exp. Date 8/31/202;

Source

Official record: FDA (Drug enforcement) ↗

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