Mephyton (phytonadione) Tablets 5mg, 100-count bottle, Rx Only, Manufactured for: Valeant Pharmaceuticals North America, LLC Bridgewater, NJ 08807 USA NDC 0187-1704-05
Reported: February 3, 2021 Initiated: January 7, 2021 #D-0243-2021
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.
Details
- Recalling Firm
- Bausch Health Companies, Inc.
- Units Affected
- 895 bottles
- Distribution
- Distributed Nationwide in the USA
- Location
- Bridgewater, NJ
Frequently Asked Questions
What product was recalled? ▼
Mephyton (phytonadione) Tablets 5mg, 100-count bottle, Rx Only, Manufactured for: Valeant Pharmaceuticals North America, LLC Bridgewater, NJ 08807 USA NDC 0187-1704-05. Recalled by Bausch Health Companies, Inc.. Units affected: 895 bottles.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications:Out of specification during the 24 month stability testing of Impurity D.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 3, 2021. Severity: Low. Recall number: D-0243-2021.
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