EMA Initiates EU Recall of Valsartan from Chinese Pharma Company

By Akia Thorpe -

July 10, 2018

The European Medicines Agency (EMA) has initiated a recall of the active substance, valsartan, supplied by Zhejiang Huahai Pharmaceuticals, a Linhai, China-based pharmaceutical company. As the substance is being recalled, the EMA is reviewing all medicines from the company containing valsartan.

Valsartan medicines are used to treat patients with high blood pressure in order to reduce complications such as heart attack and stroke. It is also used in patients who have had heart failure or a recent heart attack.

The review began after the company detected an impurity, N-nitrosodimethylamine (NDMA), in the valsartan active substance, which the company supplies to manufacturers producing some of the valsartan medicines available in the European Union (EU).

NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. The presence of NDMA is thought to be related to changes in the way the active substance was manufactured, according to information from the EMA.

While the review is underway, national authorities across the EU are recalling medicines containing valsartan supplied by Zhejiang Huahai Pharmaceuticals.

The EMA says it will investigate the levels of NDMA in these valsartan medicines, its possible impact on patients who have been taking them, and what measures can be taken to reduce or eliminate the impurity from future batches produced by the company. As a precaution, the agency’s review will also consider whether other valsartan medicines may be affected.

The review will be carried out by EMA’s Committee for Medicinal Products for Human Use.

Source: European Medicines Agency