Recalls / Class III
Class IIID-0638-2021
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.
- Affected lot / code info
- Lot #: 19D012P, Exp Date 07/2021; 20D096P, Exp Date 10/2022
Why it was recalled
Failed Impurities/Degradation Specifications
Recalling firm
- Firm
- Bausch Health Companies, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 400 Somerset Corporate Blvd, N/A, Bridgewater, New Jersey 08807-2867
Distribution
- Quantity
- 2,691 bottles
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2021-06-08
- FDA classified
- 2021-06-23
- Posted by FDA
- 2021-06-30
- Terminated
- 2023-02-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0638-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.