D-0474-2023 Class III Terminated
FDA drug recall D-0474-2023 was initiated by SUN PHARMACEUTICAL INDUSTRIES INC on March 9, 2023 and is designated Class III. Reason for recall: Failed Content Uniformity Specifications The recall status is terminated (terminated October 18, 2023). Affected quantity: 1,920 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- March 29, 2023
- Initiation Date
- March 9, 2023
- Termination Date
- October 18, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,920 bottles
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
Reason for Recall
Failed Content Uniformity Specifications
Distribution Pattern
USA nationwide.
Code Information
Lot # DND1541A, Exp 08/2024