Drug product
Mephyton (phytonadione) Tablets 5mg, 100-count bottle, Rx Only, Manufactured for: Valeant Pharmaceuticals North America, LLC Bridgewater, NJ 08807 USA NDC 0187-1704-05
D-0243-2021
Product summary
- Event
- Event 87093
- Status
- Terminated
- Classification
- Class III
- Quantity
- 895 bottles
- Official record key
drug-enforcement:D-0243-2021
Official wording
Reason: Failed Impurities/Degradation Specifications:Out of specification during the 24 month stability testing of Impurity D.
Code information: Lot: 18L092P, Exp 05/2021
Distribution pattern: Distributed Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Out of specification