Zhejiang Huahai Pharmaceutical, a Chinese active ingredient manufacturer, voluntarily notified the European Medicines Agency (EMA) that it had identified N-nitrosodimethylamine (NDMA), a chemical that might lead to cancer, in its valsartan provided to the European market. Medicines containing valsartan made by Huahai are being recalled across Europe, while the EMA carries out a thorough review to determine the impact.
Valsartan, a drug to treat high blood pressure and heart failure, was first developed by Novartis and has already gone off patent and is used in many medicines made by several drugmakers. Novartis has issued a statement saying it is recalling Sandoz's valsartan and valsartan HCT distributed in 23 countries due to the impurity, while its Novartis branded products and those made for the US are not affected.
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