(RNN) – A worldwide recall initiated last month for medicines containing valsartan medicine was extended by the Food and Drug Administration last week and in South Korea on Monday.
The revocation of the recall is linked to the presence of a possible carcinogenic contamination, a chemical compound called NDMA.
Valsartan is a common medicine used to treat high blood pressure and certain cardiac conditions. Its trademark, Diovan, produced by Novartis, is unaffected.
The FDA first issued a new list of companies affected by tainted valsartan on Thursday. It comprised four smaller companies ̵
1; Bryant Ranch Prepack, HJ Harkins Company, Proficient Rx and Northwind Pharmaceuticals – who receive the drug in bulk from a supplier and repackage it at smaller rates for hospitals and pharmacies.
The original July collection had already included a major global pharmaceutical company, Teva Pharmaceuticals. Two companies that package and distribute Teva drugs, Major Pharmaceuticals and Actavis were listed in the recall. Others included AvKARE, Remedy Repack, AS Medication Solutions and Solco Healthcare.
The contamination has been tracked for medicinal products derived from China, by a company called Zhejiang Huahai Pharmaceuticals, which supplies drug manufacturers such as Teva the raw chemical valsartan with generics.
The company’s US subsidiary is located in New Jersey. The New York Times reported, referring to a pharmaceutical industry’s research company, that one of the companies involved, Solco, is owned by Zheijiang Huahai and controls about 45 percent of the US dollar valsartan market as of last year.
“When we identify dropouts in the quality of drugs and problems with their manufacturing that are potentially at risk for patients, we are determined to take swift action to warn the public and help ease the products removed from the market” Scott Gottlieb, FDA Commissioner, said after the original revocation announcement last month.
People on the drug are recommended to look at their bottle labels to see if it comes from one of the affected companies, and the FDA says patients should “continue to take their medication until they have a replacement product.”
FDA’s European counterpart , The European Medicines Agency (EMA), also issued a revocation and conducted a review of valsartan produced by Zhejiang Huahai.
EMA discontinued the risk.
“It is important to note that there is no immediate risk to patients,” said the agency in an update issued on Thursday. “Patients taking the affected medicines that have not yet switched to an alternative should not stop taking the medicine without consulting their doctor or pharmacist.”
On Monday, South Korea expanded its own recall, Yonhap News Agency reported. The country’s Food and Drug Safety Ministry recalled 59 more drugs containing valsartan, which focused on a drug producer Daebong, who had received the ingredient from another Chinese company, Zhuhai Rundu Pharmaceuticals.
Taiwan also issued a revocation target for Zhuhai Rundu on Thursday.
It is not clear if Zhuhai Rundu delivers Valsartan to some American companies, but on its website it says it sells its products to the US market.
A list of non-recalled valsartan products is available on the FDA website Copyright 2018 Raycom News Network. All rights reserved.