FDA (Drugs) recall action 80701
The FDA (Drugs) publishes a recall like this one as 3 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 3 pages.
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
The agency’s own wording, quoted from the enforcement report.
NuCare Pharmaceuticals is recalling Valsartan/HCTZ 320/25mg tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.
NuCare Pharmaceuticals is recalling specific lots of Valsartan/HCTZ 160/25mg tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.
NuCare Pharmaceuticals is recalling specific lots of Valsartan/HCTZ tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.