Bausch Health Companies, Inc.: Drug Recall
Recall #D-0243-2021 · 01/07/2021
Class III: Low Risk
Recall Details
- Recall Number
- D-0243-2021
- Classification
- Class III
- Product Type
- Drug
- Recalling Firm
- Bausch Health Companies, Inc.
- Status
- Terminated
- Date Initiated
- 01/07/2021
- Location
- Bridgewater, NJ, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 895 bottles
Reason for Recall
Failed Impurities/Degradation Specifications:Out of specification during the 24 month stability testing of Impurity D.
Product Description
Mephyton (phytonadione) Tablets 5mg, 100-count bottle, Rx Only, Manufactured for: Valeant Pharmaceuticals North America, LLC Bridgewater, NJ 08807 USA NDC 0187-1704-05
Distribution Pattern
Distributed Nationwide in the USA
Other Recalls by Bausch Health Companies, Inc.
- Class II: Risk 02/02/2024
- Class III: Low Risk 06/08/2021
- Class III: Low Risk 06/08/2021
- Class III: Low Risk 01/07/2021
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.