Wednesday, 21 November, 2018

Chinese drug maker recalls valsartan products in US over impurity

Chinese drug maker recalls valsartan products in US over impurity Chinese drug maker recalls valsartan products in US over impurity
Samantha Long | 18 July, 2018, 17:27

The FDA has named the companies which will engage in a voluntary recall of their products - it includes Teva Pharmaceuticals, Major Pharmaceuticals and Solco Healthcare for their valsartan medicine, and Teva and Solco for their valsartan/hydrochlorothiazide (HCTZ) medicine.

Valsartan is used to treat high blood pressure and heart failure, according to the FDA.

These products - with the active ingredient valsartan, a generic drug used to treat high blood pressure - may contain N-nitrosodimethylamine (NDMA), a possible human carcinogen. The presence of NDMA is thought to be related to changes in the way the active substance was manufactured.

The companies can manufacture and sale valsartan medicine made from valsartan raw material imported from other qualified sources, the statement said. The department added that it is in continuous contact with World Health Organization, institutions and other health organization for medicines and pharmaceuticals.

Anyone taking the information should also call their doctor or pharmacist to figure out what medication they should take. Not all medicines containing the ingredient have been recalled. When contacted, DRAP deputy director (quality control) Abdul Sattar Sohrani confirmed the recall orders and said the pharmaceutical firms concerned had been given one week to remove from the market the medicines made from Zhejiang Huahai's valsartan.

Islamabad:The drug regulator has ordered the immediate recall of some heart medicines for containing a potentially cancer-causing chemical.

For more information, visit the FDA's website.

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Zhejiang Huahai, which was founded in 1989 and listed on the Shanghai stock exchange in 2003, was one of the first Chinese companies to get drugs approved in the US market.

This recall is being conducted with the full knowledge of the U.S. FDA.

According to Scott Gottlieb, the FDA commissioner "The FDA is committed to maintaining our gold standard for safety and efficacy".

Both the FDA and EMA are further investigating.

The Ministry of Health and Wellness will continue to follow warnings from the global regulatory agencies with respect to any changes in pharmaceutical products to continue to ensure the availability of safe and quality products to the public.

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

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