Drug product
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
D-0474-2023
Product summary
- Event
- Event 91871
- Status
- Terminated
- Classification
- Class III
- Quantity
- 1,920 bottles
- Official record key
drug-enforcement:D-0474-2023
Official wording
Reason: Failed Content Uniformity Specifications
Code information: Lot # DND1541A, Exp 08/2024
Distribution pattern: USA nationwide.
Derived failure modes
-
Potency or specification failure
Failed Content Uniformity Specifications