Chinese drug maker recalls valsartan products in U.S. over impurity

Source: Xinhua| 2018-07-17 22:14:17|Editor: Xiang Bo
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HANGZHOU, July 17 (Xinhua) -- A Chinese pharmaceutical company has announced a recall of blood pressure medicines containing valsartan from the U.S. market after an impurity was found.

Zhejiang Huahai Pharmaceutical Co. Ltd said in a statement issued Monday that it has also halted the supply of valsartan to the U.S. market and may face losses due to financial obligations related to the recall.

During an assessment of improving the manufacturing process, Huahai found valsartan was tainted by a minute level of N-nitrosodimethylamine (NDMA), a genotoxic substance that could cause cancer, based on results from animal tests, according to another statement issued by the company on July 7.

After the discovery, the company immediately suspended the manufacturing and supply of valsartan, sealed its stock, and informed customers and drug regulators. It also announced the recall of valsartan products in Chinese and European markets.

Valsartan products are used to treat patients with high blood pressure. The drug, manufactured by Huahai, was exported to the Americas, Europe, as well as India and Russia.

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