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FDA recalls medications used to treat high blood pressure over cancer concerns

Staff Writer |
The U.S. Food and Drug Administration has issued a voluntary recall of several medications that contain the active ingredient valsartan, which is used to treat high blood pressure and heart failure.

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“This recall is due to an impurity, N-nitrosodimethylamine (NDMA), which was found in the recalled products, the FDA said in a statement Saturday. “However, not all products containing valsartan are being recalled.”

Officials say NDMA is classified as a probable human carcinogen. They said those findings are based on results from recent laboratory tests.

The administration said the carcinogen’s presence is “thought to be related to changes in the way the active substance was manufactured.”

The Food and Drug Administration said that Prinston Pharmaceutical Inc. dba Solco Healthcare LLC. is recalling all lots of Valsartan Tablets, 40 mg, 80mg, 160mg, and 320mg; and Valsartan-Hydrochlorothiazide Tablets, 80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg, and 320mg/25mg to the retail level.

FDA announced voluntary recall of several drug products containing the active ingredient valsartan, used to treat high blood pressure and heart failure.

FDA said that the recall is due to the detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA), made by the manufacturer - Zhejiang Huahai Pharmaceutical Co. Ltd. This impurity has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification.

The U.S. recall includes the the versions of valsartan that are made by Major Pharmaceuticals, Solco Healthcare and Teva Pharmaceuticals Industries Ltd. as well as valsartan/hydrochlorothiazide (HCTZ) sold by Solco Healthcare and Teva Pharmaceuticals Industries Ltd.


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