The agency is telling that traces of N-nitrosodimethylamine (NDMA) "probable human carcinogen", was found in the active ingredient valsartan in the recalled products.
- Because valsartan is used in medicines to treat serious medical conditions, patients taking the recalled valsartan-containing medicines should continue taking their medicine until they have a replacement product.
Valsartan products are used to treat patients with high blood pressure.
Based on some laboratory tests, researchers have determined that NDMA could cause cancer.More news: Ethiopia & Eritrea declare end to 20-year war
Zhejiang Huahai has already acknowledged that there was an impurity in some of its valsartan, which it said had sales of $50 million in 2017.
The FDA advises that patients contact pharmacists or physicians for advice on alternate therapy in lieu of the recalled treatment.
The ministry said it withdrew all the pharmaceutical products that contain the active substance, once it received the memo. The US recall includes the the versions of valsartan that are made by Major Pharmaceuticals, Solco Healthcare and Teva Pharmaceuticals Industries Ltd.as well as valsartan/hydrochlorothiazide (HCTZ) sold by Solco Healthcare and Teva Pharmaceuticals Industries Ltd.
After the discovery, the company immediately suspended the manufacturing and supply of valsartan, sealed its stock, and informed customers and drug regulators. "This is why we've asked these companies to take immediate action to protect patients", said Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, in a statement.More news: This C-SPAN caller thinks Russian Federation meddled, and she's glad about it
According to the ministry, the list of recalled products has been posted on the websites of regulatory agencies, including the US Food and Drug administration, Health Canada, the Irish Regulatory Authority and the Jamaica Ministry of Health.
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 USA market.
"The FDA is committed to maintaining our gold standard for safety and efficacy", said FDA Commissioner Scott Gottlieb, M.D.
According to the EMA, it is investigating the levels of NDMA in these valsartan medications, its possible impact on users, and steps to reduce or eliminate the impurity from future batches produced by the Chinese company.More news: European Union to sign its biggest free trade deal with Japan
"It's not just valsartan", said Lever.