Recall Enforment Report D-0243-2021
Recall Details
Multi event Drug Recall Enforcement Report Class III voluntary initiated by Bausch Health Companies, Inc., originally initiated on 01-07-2021 for the 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 The product was recalled due to failed impurities/degradation specifications:out of specification during the 24 month stability testing of impurity d.. The product was distributed nationwide and the recall is currently terminated.
Recall Enforcement Reports
| Recall Number | Recall Initiation Date | Report Date | Recall Classification | Quantity | Product Description | Recall Reason | Status |
|---|---|---|---|---|---|---|---|
| D-0243-2021 | 01-07-2021 | 02-03-2021 | Class III | 895 bottles | Mephyton (phytonadione) Tablets 5mg, 100-count bottle, Rx Only, Manufactured for: Valeant Pharmaceuticals North America, LLC Bridgewater, NJ 08807 USA NDC 0187-1704-05 | Failed Impurities/Degradation Specifications:Out of specification during the 24 month stability testing of Impurity D. | Terminated |
| D-0244-2021 | 01-07-2021 | 02-03-2021 | Class III | 14,089 bottles | Phytonadione Tablets 5mg, 30-count bottle, Rx Only, Manufactured For: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA NDC 68682-170-30 | Failed Impurities/Degradation Specifications:Out of specification during the 24 month stability testing of Impurity D. | Terminated |
