Chinese drug maker recalls valsartan products in US over impurity

Chinese drug maker recalls valsartan products in US over impurity

The U.S. Food and Drug Administration is alerting health care professionals and patients of a recall of several drugs that contain the ingredient valsartan.

The drug regulator has clarified that valsartan medicine made by Pakistani companies is not banned and only batches manufactured by using valsartan as a raw material, and supplied by Zhejiang Huahai Pharmaceuticals, China are being recalled.

It has been brought to the attention of the Ministry of Health and Wellness that some batches of Valsartan, a popular drug used to treat high blood pressure, is the subject of an worldwide recall.

NDMA is classified as a probable human carcinogen based on lab tests. Also, the FDA said there is a link between valsartan and cancer. The department added that it is in continuous contact with World Health Organization, institutions and other health organization for medicines and pharmaceuticals.

At the time of the announced recall, Teva had not received any reports of adverse events related to the recall of 29 single lots and 51 combinations lots of valsartan.

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To determine whether a specific product has been recalled, patients should look at the drug name and company name on the label of their prescription bottle. "That is why we've asked these companies to take immediate action to protect patients". "EMA has made this aspect of the review a priority and will update the public as soon as new information becomes available", the agency said.

Companies impacted by the recall have shared instructions for patients impacted by these products.

The case shows the reliance of consumers around the world on medicines containing active pharmaceutical ingredients made in China. Zhejiang Huahai Pharmaceuticals supplied the three US -based pharmaceutical companies with these products, according to The New York Times. Pharmacies in the United Kingdom are advised to recall valsartan batches containing medicines made by Dexcel Pharma Ltd and Accord Healthcare. "That includes our efforts to ensure the quality of drugs and the safe manner in which they're manufactured", said FDA Commissioner Scott Gottlieb, M.D. In some patients, vulsartan is becoming life-saving medicine.

"It's not just valsartan", said Lever.

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