Reported Feb 3, 2021 · Terminated
Mephyton (phytonadione) Tablets 5mg, 100-count bottle, Rx Only, Manufactured for: Valeant Pharmaceuticals North…
Bausch Health Companies, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Bausch Health Companies, Inc. · 400 Somerset Corporate Blvd · Bridgewater, NJ · 08807-2867
Is this the product you have?
Mephyton (phytonadione) Tablets 5mg100-count bottleRx Only
- Manufactured forValeant Pharmaceuticals North America, LLC Bridgewater, NJ 08807 USA NDC 0187-1704-05
- Lot codes and dates
- Lot
18L092PExp 05/2021
- Lot
- Amount recalled
- 895 bottles
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Failed Impurities/Degradation Specifications:Out of specification during the 24 month stability testing of Impurity D.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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