FDA (Drugs) recall action 87093
The FDA (Drugs) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
Failed Impurities/Degradation Specifications:Out of specification during the 24 month stability testing of Impurity D.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Bausch Health is recalling 895 bottles of Mephyton (phytonadione) 5mg tablets because Impurity D failed stability testing specifications.
Bausch Health is recalling Phytonadione Tablets 5mg because Impurity D exceeded specifications during stability testing. The recall covers 14,089 bottles distributed nationwide.