Product: Simvastatin Tablets USP 20 mg Rx Only, Packaged as: a) 90-count bottle NDC 16729-005-15, UPC 3 16729 00515 9; b) 1,000-count bottle NDC 16729-005-17, UPC 3 16729 00517 3; 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