Valsartan, a common drug used to control hypertension and heart failure, is being recalled in 22 counties due to concerns its active pharmaceutical ingredient, N-Nitrosodimethylamine (NDMA), a known carcinogen, poses a cancer risk.
The recalled batches were supplied by China’s Zhejiang Huahai Pharmaceuticals.
“A recall is underway across Europe following recent and emerging information that an impurity has been identified as part of the manufacturing process in a valsartan active substance manufactured at one facility based in China,” read an issued statement from the Medicines and Healthcare products Regulatory Agency in the U.K. “This facility has supplied the manufacturers with the valsartan active substance. The impurity (N-nitrosodimethylamine), which may have carcinogenic potential, is a result of a change in the manufacturing process. This active substance is used in a number of medicines marketed in Europe.”