D-0638-2021 Class III Terminated
FDA drug recall D-0638-2021 was initiated by Bausch Health Companies, Inc. on Jun 8, 2021 and is designated Class III. Reason for recall: Failed Impurities/Degradation Specifications The recall status is terminated (terminated Feb 16, 2023). Affected quantity: 2,691 bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Jun 30, 2021
- Initiation Date
- Jun 8, 2021
- Termination Date
- Feb 16, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,691 bottles
Product description
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.
Reason for recall
Failed Impurities/Degradation Specifications
Distribution pattern
Nationwide within the United States
Code information
Lot #: 19D012P, Exp Date 07/2021; 20D096P, Exp Date 10/2022
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0638-2021
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026