The ANMAT instructs holders of medicinal certificates to refrain from acquiring and using the active ingredient (IFA) VALSARTAN, prepared by Zhejiang Juahai Pharmaceutical Co. Ltd, Channan Site, RC-317016, China. The recommendation is based on statements issued by the European Medicines Agency (EMA) and by the Spanish Agency for Medicines and Healthcare Products (AEMPS), as a result of which the processor detected a potentially cytotoxic impurity (N-nitrosodimethylamine) in the pharmaceutical ingredient active Valsartan, after a change in the manufacturing process of the IFA. This Administration is evaluating the pertinent sanitary measures to take, as a consequence of this episode.
Source: http://www.anmat.gov.ar/comunicados/Valsartan_China.pdf