Simvastatin Tablets USP 80 mg Rx Only, Packaged as: a) 90-count bottle NDC 16729-007-15, UPC 3 16...
FDA Recall #D-0412-2023 — Class II — February 7, 2023
Product Description
Simvastatin Tablets USP 80 mg Rx Only, Packaged as: a) 90-count bottle NDC 16729-007-15, UPC 3 16729 00715 3; b) 1,000-count bottle NDC 16729-007-17, UPC 3 16729 00717 7; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA
Reason for Recall
CGMP Deviations: recalling drug products following an FDA inspection.
Recalling Firm
Accord Healthcare, Inc. — Durham, NC
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
205,631 bottles
Distribution
United States including Puerto Rico and Canada
Code Information
Batches: a) R2100387, R2100393, Exp. Date 2/28/2023, P2102556, P2102558, P2102636, Exp. Date 4/30/2023, P2103981, P2103877, P2103958, Exp. Date 5/31/2023, R2101393, R2101395, R2101394, Exp. Date 10/31/2023, P2202681, P2202653, Exp. Date 4/30/2025; b)R2000555, R2000587, R2000599, R2000604, Exp. Date 9/30/2023; P2100023, P2006857, Exp. Date 11/30/2023, P2101094, P2101096, P2101110, P2101111, P2101113, P2101145, P2101198, P2101223, P2101199, Exp. Date 1/31/2024, P2101877, P2101885, P2101886, P2101929, R2100402, R2100406, R2100403, Exp. Date 2/28/2024, P2101786, P2101787, P2101789, P2101790, Exp. Date 2/29/2024, R2100440, R2100439, Exp. Date 3/31/2024
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated