FDA Announces Recall of Valsartan-containing Products
18 July, 2018, 17:26 | Author: Sherman Richardson
The Pharmacy and Drug Control department at the ministry said it received memos from global organizations on the possibility of a carcinogenic flaw called n-nitrosodimethylamine (NDMA) in the active substance (Valsartan) manufactured by the company.
Because valsartan is used in medicines to treat serious medical conditions, patients taking the recalled valsartan-containing medicines are being advised to continue taking their medicine until they have a replacement product, according to the FDA. The impurity detected in the API is N- nitrosodimethylamine (NDMA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification. "The presence of of NDMA was unexpected and is thought to be related to changes in the way the active substance was manufactured", the FDA release said.
The companies can manufacture and sale valsartan medicine made from valsartan raw material imported from other qualified sources, the statement said.
The FDA advises that patients contact pharmacists or physicians for advice on alternate therapy in lieu of the recalled treatment.
Companies which are recognized pharmaceuticals are Major Pharmaceuticals, Teva Pharmaceuticals, Solco Healthcare.
After the discovery, the company immediately suspended the manufacturing and supply of valsartan, sealed its stock, and informed customers and drug regulators.
For more information, visit the FDA's website.
The recalled medications have the have valsartan in them.
FDA is spending time in reviewing the drug and in the meantime, three companies which are based in the United States has refused to sell the medications which are containing valsartan.
This recall is being conducted with the full knowledge of the U.S. FDA. "That includes our efforts to ensure the quality of drugs and the safe manner in which they're manufactured", Commissioner Dr. Scott Gottlieb said Friday. FDA is assuring the public that they are investigating with their proper efficiency and they will find out all the products which are creating the bad impacts. "It just makes me wonder if there's a link", Meade said.
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