Bausch Health is recalling approximately 14,984 bottles of Mephyton (phytonadione) 5mg tablets and generic Phytonadione 5mg tablets. The recall was initiated because the medication failed to meet stability specifications for an impurity during 24-month testing. Consumers should check their medicine bottles for the specific affected lot numbers to ensure they are not taking degraded medication.
The medication was found to contain levels of an impurity (Impurity D) that exceed approved safety and quality specifications after being stored for two years. This degradation may mean the drug does not perform as expected or contains higher than intended levels of non-active substances.
Drug recall guidance for pharmacists and consumers
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Sources: FDA iRES · Raw API Response
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