EMA recalls drugs made with Chinese API due to cancer fears

July 6, 2018

The European Medicines Agency is recalling a number of high blood pressure and heart drugs containing an ingredient made in China after an impurity that may cause cancer was found in them.

The impurity —  N-nitrosodimethylamine (NDMA) — was found in the API valsartan, manufactured by Zhejiang Huahai Pharmaceuticals, a company in Linhai, China. Regulators said said the appearance of the impurity came after a change in the process for making valsartan at one facility.

Valsartan is an angiotensin-II-receptor antagonist used to treat hypertension, recent heart attack, and heart failure. It was originally developed by Novartis and marketed it as Diovan, but it is now off patent and is used in a number of generic medicines.

Read the EMA report