Drug product
Digoxin Tablets, USP 62.5 mcg (0.0625 mg), 100-count bottles, Rx Only, Manufactured by: Novitium Pharma LLC, 70 Lake Drive, East Windsor, New Jersey 08520, NDC 70954-200-10
D-0443-2024
Product summary
- Event
- Event 94255
- Status
- Terminated
- Classification
- Class III
- Quantity
- 1,003 bottles
- Official record key
drug-enforcement:D-0443-2024
Official wording
Reason: Failed Impurities/Degradation Specifications
Code information: Lot M23011A; Exp. 12/2024
Distribution pattern: U.S. Nationwide
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications