FDA (Drugs) recall action 80557
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.
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
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.
Major Pharmaceuticals is recalling specific lots of 80 mg Valsartan tablets because a carcinogen impurity was detected in the active ingredient.
Major Pharmaceuticals is recalling specific lots of 160 mg Valsartan tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.