FDA updates health care professionals and patients on recent valsartan recalls

FDA is updating health care professionals and consumers following a recent FDA press release about voluntary recalls of several drug products containing the active pharmaceutical ingredient (API) valsartan. Valsartan is used to treat high blood pressure and heart failure. FDA recommends patients use valsartan-containing medicines made by other companies or consider other available treatment options for the patient's medical condition. Not all products containing valsartan are being recalled, and this update will clarify which valsartan-containing products are being recalled. The recalled products contain an impurity, N-nitrosodimethylamine (NDMA), in the API manufactured by China-based Zhejiang Huahai Pharmaceuticals. The presence of the potentially cancer-causing NDMA was unexpected, and the agency believes the NDMA is related to changes in the way the active substance was manufactured. Some levels of the impurity may have been in the valsartan-containing products for as long as 4 years. There are currently three voluntary recalls related to the NDMA impurity detected in the valsartan API: Teva Pharmaceuticals USA labeled as Major Pharmaceuticals—recall is at the retail level; Prinston Pharmaceuticals Inc. labeled as Solco Healthcare LLC—recall is at the consumer/user level; and Teva Pharmaceuticals labeled as Actavis LLC—recall is at the consumer/user level. The investigation into valsartan-containing products is ongoing, and the agency will update this statement as it has more information.

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