MedicineWatch US
Class II Recall

Accord Healthcare, Inc.

Product
Atorvastatin Calcium Tablets USP 20 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-045-15 UPC 3 16729 04515 5; b) 1,000 Tablets NDC 16729-045-17 UPC 3 16729 04517 9, 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)R2100305, Exp. Date 2/28/2023; R2200227, Exp. Date 1/31/2024; R2200797, Exp. Date 6/30/2024; b) R2101423, R2101438, R2101447, R2101446, Exp. Date 10/31/2023; R2200040, R2200041, R2200052, R2200043, R2200044, R2200051, R2200060, R2200061, R2200062, R2200077, R2200078, Exp. Date 12/31/2023; R2200228, R2200480, Exp. Date 1/31/2024; R2200266, R2200267, R2200265, R2200268, Exp. Date 2/29/2024; R2200370, Exp. Date 3/31/2024; R2201038, Exp. Date 6/30/2024;
Date
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.
Accord Healthcare, Inc. — Class II Recall | MedicineWatch US