FDA (Drugs) recall action 80525
The FDA (Drugs) publishes a recall like this one as 9 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 9 pages.
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
The agency’s own wording, quoted from the enforcement report.
Prinston Pharmaceutical Inc. is recalling Valsartan tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.
Prinston Pharmaceutical Inc is recalling Valsartan and Hydrochlorothiazide tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.
Prinston Pharmaceutical Inc. is recalling Valsartan and Hydrochlorothiazide tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.
Prinston Pharmaceutical Inc. is recalling Valsartan and Hydrochlorothiazide tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.
Prinston Pharmaceutical Inc is recalling Valsartan and Hydrochlorothiazide tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.
Prinston Pharmaceutical Inc is recalling Valsartan tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.
Prinston Pharmaceutical Inc is recalling Valsartan tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.
Prinston Pharmaceutical Inc. is recalling Valsartan 40 mg tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.
Prinston Pharmaceutical Inc is recalling Valsartan and Hydrochlorothiazide tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.