FDAnews Drug Daily Bulletin
Pharmaceuticals / Postmarket Safety

EMA Recalls Medicines From Chinese Firm That Contain Valsartan

July 10, 2018
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Following the discovery of an impurity in valsartan active substances supplied by a Chinese company to EU manufacturers, the European Medicines Agency launched a review and recall of the products.

The company, Zhejiang Huahai Pharmaceuticals, detected the impurity, N-nitrosodimethylamine (NDMA) in its valsartan active substance, which it supplies to manufacturers as a component of certain valsartan medicines available in the EU.

The review will assess the levels of NDMA in the valsartan drugs, the possible impact on patients that have been taking them and actions that can be taken to reduce or eliminate the impurity from future batches.

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