Mephyton recall: Impurity Out of Spec
Mephyton (phytonadione) Tablets 5mg, 100-count bottle, Rx Only, Manufactured for: Valeant Pharmaceuticals North America, LLC Bridgewater, NJ 08807 USA…
Why was Mephyton recalled?
Failed Impurities/Degradation Specifications:Out of specification during the 24 month stability testing of Impurity D.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot: 18L092P, Exp 05/2021
- Product
- Mephyton (phytonadione) Tablets 5mg, 100-count bottle, Rx Only, Manufactured for: Valeant Pharmaceuticals North America, LLC Bridgewater, NJ 08807 USA…
- Recalling firm
- Bausch Health Companies, Inc.
- Quantity
- 895 bottles
- Distribution
- Distributed Nationwide in the USA
- Recall date
- February 3, 2021
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)