Recalls / Class III
Class IIID-0639-2021
Product
Phytonadione Tablets, 5 mg, 30-count ablets, Rx only, Manufactured for: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA, NDC 68682-170-30
- Affected lot / code info
- Lot #:19D013P, Exp Date 07/2021; 20D099P, 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
- 37,797 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-0639-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.