Drug 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
D-1082-2023
Product summary
- Event
- Event 92725
- Status
- Terminated
- Classification
- Class III
- Quantity
- 360 60-count bottles
- Official record key
drug-enforcement:D-1082-2023
Official wording
Reason: Out of Specification result observed in content uniformity testing
Code information: Lot: DNE0217A, Exp 01/2025
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Out of Specification