FDA (Drugs) recall action 68572
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.
Labeling: Incorrect or Missing Package Insert: Product is packaged with the incorrect version of the package insert.
Labeling: Incorrect or Missing Package Insert: Product is packaged with the incorrect version of the package outset
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.
Valeant Pharmaceuticals is recalling 205,853 bottles of Vasotec (enalapril maleate) tablets because they were packaged with the incorrect version of the package insert.
Valeant Pharmaceuticals is recalling Vaseretic tablets because they were packaged with the incorrect version of the package insert.