Accord Healthcare, Inc. — Class II Recall

Product

Simvastatin Tablets, USP, 10 mg, Rx Only, Packaged as: a) 90-count bottle NDC 16729-004-15, UPC 3 16729 00415 2; b) 1,000-count bottle NDC 16729-004-17, UPC 3 16729 00417 6; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA

Reason

CGMP Deviations: recalling drug products following an FDA inspection.

Classification

Class II

Status

Terminated

Lot

Batches: a) P2106923, Exp. Date 9/30/2023; R2101544, Exp. Date 10/31/2023; R2200732, Exp. Date 5/31/2025; b) P2101634, Exp. Date 2/28/2023; P2102370, Exp. Date 3/31/2023; P2102321, Exp. Date 3/31/2023; P2102411, Exp. Date 3/31/2023; P2102454, Exp. Date 3/31/2023; P2103991, Exp. Date 5/31/2023; R2100954, Exp. Date 6/30/2023; R2100947, Exp. Date 6/30/2023; R2100951, Exp. Date 6/30/2023; P2106242, Exp. Date 8/31/2023; P2106928, Exp. Date 9/30/2023; P2107424, Exp. Date 9/30/2023; R2101542, Exp. Date 10/31/2023; R2101543, Exp. Date 10/31/2023; R2200026, Exp. Date 11/30/2023; R2200414, Exp. Date 2/29/2024; R2200416, Exp. Date 2/28/2025; R2200586, Exp. Date 4/30/2025; R2200679, Exp. Date 5/31/2025; R2200824, Exp. Date 5/31/2025;

Date

2023-03-08

Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.