Drug product
Mephyton (Phytonadione) 5 mg tablets, 100-count tablets, Rx Only, Manufactured for: Valeant Pharmaceuticals North America, LLC, Bridgewater, NJ, 08807, USA, NDC 0187-1704-05.
D-0638-2021
Product summary
- Event
- Event 88079
- Status
- Terminated
- Classification
- Class III
- Quantity
- 2,691 bottles
- Official record key
drug-enforcement:D-0638-2021
Official wording
Reason: Failed Impurities/Degradation Specifications
Code information: Lot #: 19D012P, Exp Date 07/2021; 20D096P, Exp Date 10/2022
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications