Accord Healthcare, Inc. recalls Atorvastatin Calcium Tablets USP 80 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-047-15 UPC 3 16729 04715 9; b) 500
Recalled March 8, 2023 · FDA recall D-0374-2023 · Accord Healthcare
Hazard
CGMP Deviations: recalling drug products following an FDA inspection. · FDA Class II
Units
72,376 bottles
Sold at
United States including Puerto Rico and Canada
Description
CGMP Deviations: recalling drug products following an FDA inspection.
Product
Atorvastatin Calcium Tablets USP 80 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-047-15 UPC 3 16729 04715 9; b) 500 Tablets NDC 16729-047-16 UPC 3 16729 04716 6; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA
Manufacturer(s)
Accord Healthcare, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →