FDA joins EU in seeking recall of certain Chinese-made valsartan products over potential cancer risk

Recalls of certain drugs containing heart drug valsartan supplied by Zhejiang Huahai Pharmaceutical have spread to the U.S., as the FDA sought voluntary actions to take some affected drugs off the shelves due to the potential cancer risk.

The recall, like the one announced earlier by the European Medicines Agency, is because the API in those drugs was unexpectedly tainted with N-nitrosodimethylamine (NDMA), a substance that could cause cancer.

The recalled finished products in the U.S. include all non-expired generic valsartan sold by Major Pharmaceuticals, Teva and Huahai’s U.S. subsidiary, Solco Healthcare, as well as valsartan/hydrochlorothiazide (HCTZ) made by Teva and Solco. Valsartan’s original developer Novartis previously told FiercePharma none of its valsartan...