Product: Dofetilide Capsules 500 mcg (0.5mg), 60-count bottle, Rx Only, Manufactured by Sun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396 191, (U.T of D & NH), India,  Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512. NDC 47335-063-86
Reason for recall: Out of Specification result observed in content uniformity testing
Recall initiated: 20230718
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated