Bulgaria’s medicines agency said on July 6 that it was suspending the sale of 62 high blood pressure and heart medications, as part of a Europe-wide recall, after a potentially harmful impurity was found in the active substance manufactured in China.
The drugs affected contain the valsartan active substance, which is used to treat high blood pressure, recent heart attack and heart failure.
A review underway by the European Medicines Agency (EMA) and national agencies focused on medicines containing valsartan manufactured by China’s Zhejiang Huahai Pharmaceuticals, the medicines agency said. The review was triggered after the company detected an impurity, N-nitrosodimethylamine (NDMA), a substance classified as “probable cancerogen”.
The presence of the impurity was believed to be related to changes in the manufacturing process of valsartan. The EMA and national agencies were working with Zhejiang Huahai Pharmaceuticals on measures to reduce or remove altogether the impurity in future batches of valsartan produced at at company’s facility, the Bulgarian medicines agency said.