Product: Tadalafil Tablets, USP, 2.5 mg Rx Only, Packaged as:  a) 30-count bottle NDC 16729-369-10, UPC 3 16729 36910 7; b) 500-count bottle  NDC 16729-369-16, UPC 3 16729 36916 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.
Recall initiated: 20230207
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated