FDA (Drugs) recall action 80828
The FDA (Drugs) publishes a recall like this one as 4 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 4 pages.
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
The agency’s own wording, quoted from the enforcement report.
AvKARE Inc. is recalling Valsartan Tablets 320 mg because a carcinogen impurity was detected in the active pharmaceutical ingredient.
AvKARE is recalling Valsartan Tablets 40 mg because a carcinogen impurity was detected in the active pharmaceutical ingredient used to manufacture the drug.
AvKARE is recalling specific lots of Valsartan 80 mg tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.
AvKARE, Inc. is recalling specific lots of Valsartan Tablets 160 mg because a carcinogen impurity was detected in the active pharmaceutical ingredient used to manufacture the drug.