Dofetilide Capsules, 500 mcg (0.5 mg), 60-count bottle, Rx only, Manufactured by: Sun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India, NDC 47335-0063-86
Recall Number: D-0474-2023
Firm: SUN PHARMACEUTICAL INDUSTRIES INC
Classification: Class III
Status: Terminated
Report Date: 20230329
Initiation Date: 20230309
Termination Date: 20231018
Reason for Recall
Failed Content Uniformity Specifications
Product Description
Dofetilide Capsules, 500 mcg (0.5 mg), 60-count bottle, Rx only, Manufactured by: Sun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India, NDC 47335-0063-86