D-0243-2021 Class III Terminated
FDA drug recall D-0243-2021 was initiated by Bausch Health Companies, Inc. on Jan 7, 2021 and is designated Class III. Reason for recall: Failed Impurities/Degradation Specifications:Out of specification during the 24 month stability testing of Impurity D. The recall status is terminated (terminated Feb 11, 2022). Affected quantity: 895 bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Feb 3, 2021
- Initiation Date
- Jan 7, 2021
- Termination Date
- Feb 11, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 895 bottles
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
Reason for recall
Failed Impurities/Degradation Specifications:Out of specification during the 24 month stability testing of Impurity D.
Distribution pattern
Distributed Nationwide in the USA
Code information
Lot: 18L092P, Exp 05/2021
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0243-2021
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026