China's Valsartan ingredient maker started voluntary recalls

0 Comment(s)Print E-mail Xinhua, July 30, 2018
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A major Chinese producer of Valsartan ingredients has halted shipments and launched voluntary recalls in domestic and foreign markets after detecting N-nitrosodimethylamine (NDMA) in its product, the country's drug regulator said Sunday.

Zhejiang Huahai Pharmaceutical has taken needed measures in line with regulations, according to the State Drug Administration (SDA).

The company is a supplier of active pharmaceutical ingredients (APIs) for Valsartan, which is commonly used to treat high blood pressure and heart failure.

On July 6, it reported to the drug regulator discovery of traces of N-nitrosodimethylamine (NDMA) in its products for export, a SDA spokesperson said, adding the company also revealed relevant information to the public.

Updated on the risk assessments issued by its global counterparts, the SDA has screened all of the country's seven Valsartan API suppliers including Huahai for NDMA, qualifying products of the other six makers, according to the spokesperson.

NDMA is classified as a 2A carcinogen by European and multiple drug regulators, which means there is limited evidence proving it could cause cancer to humana, and measures including halting of sales and recalls are taken for precaution while the NDMA-laced drugs are not expected to pose severe risks to patients' health, according to a statement from the SDA.

The SDA advised patients not to stop taking the affected Valsartan medicine unless they have been told to do so by their doctor. 

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