FDA recall of certain generic valsartan products adds to similar EU action on finding of impurities

On Friday, the US Food and Drug Administration alerted health care professionals and patients of a voluntary recall of several drug products containing the active ingredient valsartan, used to treat high blood pressure and heart failure.

This recall is due to an impurity, N-nitrosodimethylamine (NDMA), which was found in the recalled products. However, not all products containing valsartan are being recalled. NDMA is classified as a probable human carcinogen (a substance that could cause cancer) 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.

The FDA’s action follows last week’s announcement by the European Medicines Agency that it is reviewing medicines containing valsartan, the active ingredient of Swiss pharma giant Novartis’ now off patent Diovan, that is supplied by China-based Zhejiang Huahai Pharmaceuticals.