Accord Healthcare, Inc. recalls Tadalafil Tablets, USP, 5 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-370-10, UPC 3 16729 37010 3; b) 500-coun
Recalled March 8, 2023 · FDA recall D-0415-2023 · Accord Healthcare
Hazard
CGMP Deviations: recalling drug products following an FDA inspection. · FDA Class II
Units
1,113,264 bottles
Sold at
United States including Puerto Rico and Canada
Description
CGMP Deviations: recalling drug products following an FDA inspection.
Product
Tadalafil Tablets, USP, 5 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-370-10, UPC 3 16729 37010 3; b) 500-count bottle NDC 16729-370-16, UPC 3 16729 37016 5; 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 →