FDAJanuary 7, 2021drug
Mephyton (phytonadione) Tablets 5mg, 100-count bottle, Rx Only, Manufactured for: Valeant Pharmaceuticals North America, LLC Bridgewater, NJ 08807 USA NDC 0187-1704-05
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Failed Impurities/Degradation Specifications:Out of specification during the 24 month stability testing of Impurity D.
What to do
FDA enforcement status: Terminated
Brands named
bausch health companiesbauschbausch health
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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