EMA announced it is reviewing the possible health effects in patients who may have taken valsartan medicines containing N-nitrosodimethylamine (NDMA) – an impurity found in the active substance manufactured by Zhejiang Huahai Pharmaceuticals that is potentially carcinogenic. EMA estimates average levels of this impurity in the active substance at 60 parts per million. Medicines containing the Zhejiang Huahai API have been recalled in Europe and the US.
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