Medicines Containing Valsartan Voluntarily Recalled Following Impurity Detection

The FDA is alerting health care professionals and patients of a voluntary recall of several, but not all, drug products containing the active ingredient valsartan.

Officials with the US FDA are alerting health care professionals and patients of a voluntary recall of several, but not all, drug products containing the active ingredient valsartan, due to an impurity, N-nitrosodimethylamine (NDMA), which was found in the recalled products. NDMA is classified as a probable human carcinogen based on results from laboratory tests. The presence of NDMA was unexpected and is thought to be related to changes in the way the active substance was manufactured.

Some companies are recalling all lots of non-expired products that contain the ingredient valsartan supplied by a third-party. Not all valsartan-containing medicines distributed in the United States have valsartan active pharmaceutical ingredient (API) supplied by this specific company. The supplier has stopped distributing its valsartan API and the FDA is working with the affected companies to reduce or eliminate the valsartan API impurity from future products.

Recalled products include: Valsartan, Solco Healthcare; Valsartan, Teva Pharmaceuticals Industries Ltd.; Valsartan/Hydrochlorothiazide (HCTZ), Solco Healthcare and Valsartan/Hydrochlorothiazide (HCTZ),Teva Pharmaceuticals Industries Ltd.

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