The batches of Valsartan were found to contain N-nitrosodiethylamine (NDEA), a probable carcinogen, and were made in Mylan’s Hyderabad facility in India, the EMA said.
EU: European Union authorities on Monday stepped in to effectively ban sales of blood pressure medicine valsartan made by an India-based unit of Mylan NV after some batches were found to contain a probable cancer-causing impurity, the latest in a global crackdown.
The European regulator said the unit’s compliance certificate had been suspended, effectively prohibiting the use of its valsartan in medicines in the region.
The affected batches are being recalled and tests conducted to determine the extent of the contamination, the European Medicines Agency said https://www.ema.europa.eu/en/news/valsartan-mylan-laboratories-india-can-no-longer-be-used-eu-medicines-due-ndea-impurity on Monday.
The batches were found to contain N-nitrosodiethylamine (NDEA), a probable carcinogen, and were made in Mylan’s Hyderabad facility in India, the EMA said.
Cancer-causing impurities have been linked to batches of valsartan over the past year, leading to a global recall.
The U.S. Food and Drug Administration last month halted imports of drug ingredients or medicines made with ingredients produced at a factory belonging to a Chinese bulk manufacturer of valsartan, Zhejiang Huahai Pharmaceuticals .
Huahai has recalled valsartan products made at its factory in China’s Chuannan province after N-nitrosodimethylamine (NDMA), another impurity linked to cancer, was found.
Mylan did not immediately respond to a request for comment.
(Reporting by Tamara Mathias in Bengaluru; Editing by Maju Samuel)