Drug product
Phytonadione Tablets, 5 mg, 30-count ablets, Rx only, Manufactured for: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA, NDC 68682-170-30
D-0639-2021
Product summary
- Event
- Event 88079
- Status
- Terminated
- Classification
- Class III
- Quantity
- 37,797 bottles
- Official record key
drug-enforcement:D-0639-2021
Official wording
Reason: Failed Impurities/Degradation Specifications
Code information: Lot #:19D013P, Exp Date 07/2021; 20D099P, Exp Date 10/2022
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications