Recalls / Class III
Class IIID-0243-2021
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
- Affected lot / code info
- Lot: 18L092P, Exp 05/2021
Why it was recalled
Failed Impurities/Degradation Specifications:Out of specification during the 24 month stability testing of Impurity D.
Recalling firm
- Firm
- Bausch Health Companies, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 400 Somerset Corporate Blvd, Bridgewater, New Jersey 08807-2867
Distribution
- Quantity
- 895 bottles
- Distribution pattern
- Distributed Nationwide in the USA
Timeline
- Recall initiated
- 2021-01-07
- FDA classified
- 2021-01-25
- Posted by FDA
- 2021-02-03
- Terminated
- 2022-02-11
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0243-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.