Accord Healthcare, Inc. recalls 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-c
Recalled March 8, 2023 · FDA recall D-0412-2023 · Accord Healthcare
Hazard
CGMP Deviations: recalling drug products following an FDA inspection. · FDA Class II
Units
205,631 bottles
Sold at
United States including Puerto Rico and Canada
Description
CGMP Deviations: recalling drug products following an FDA inspection.
Product
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
Manufacturer(s)
Accord Healthcare, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →