Product: Dofetilide Capsules 250 mcg (0.25 mg) 60-count bottle, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703.  Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA NDC 16729-491-12 UPC 3 16729 49112 9
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