Drug recall D-0372-2023
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 for recall
CGMP Deviations: recalling drug products following an FDA inspection.
Lots and codes
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;
Recall details
- Recalling firm
- Accord Healthcare, Inc., Durham, NC
- Quantity
- 241,585 bottles
- Distribution
- United States including Puerto Rico and Canada
- Type
- Voluntary: Firm initiated
- Recall initiated
- February 7, 2023
- Terminated
- April 22, 2024
Related products
- Atorvastatin Calcium – drug information
- NDC 16729-044 Atorvastatin Calcium · Atorvastatin Calcium Trihydrate 10 mg/1 · Accord Healthcare Inc.
- NDC 16729-047 Atorvastatin Calcium · Atorvastatin Calcium Trihydrate 80 mg/1 · Accord Healthcare Inc.
- NDC 16729-046 Atorvastatin Calcium · Atorvastatin Calcium Trihydrate 40 mg/1 · Accord Healthcare Inc.
- NDC 16729-045 Atorvastatin Calcium · Atorvastatin Calcium Trihydrate 20 mg/1 · Accord Healthcare Inc.