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Impure valsartan API prompts recalls in EU

Hundreds of marketing authorisations held by major generics players – including Accord’s Actavis, Aurobindo, Gedeon Richter, Sandoz, Sanofi’s Zentiva, and Teva – have been affected by recalls across Europe of medicines containing valsartan, prompted by the discovery of an impurity in the active pharmaceutical ingredient (API) supplied by China’s Zhejiang Huahai. Health Canada has also issued a recall.

Hundreds of marketing authorisations held by major generics players – including Accord’s Actavis, Aurobindo, Gedeon Richter, Sandoz, Sanofi’s Zentiva, and Teva – have been affected by recalls across Europe of medicines containing valsartan, prompted by the discovery of an impurity in the active pharmaceutical ingredient (API) supplied by China’s Zhejiang Huahai. Health Canada has also issued a recall.

Announcing that it was reviewing medicines containing valsartan supplied by Zhejiang Huahai, the European Medicines Agency (EMA) agency said this was “triggered after the firm detected an impurity, N-nitrosodimethylamine (NDMA), in the valsartan active substance. NDMA was “classified as a probable human carcinogen”, the agency noted

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