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Three companies that repackage drugs withdraw drugs containing valsartan, and others should follow the same path, according to the United States Food and Drug Administration (FDA).
Products containing valsartan manufactured by Teva Pharmaceuticals and Prinston Pharmaceutals – labeled AS Medication Solutions, AvKARE and RemedyRepack – were added to the list of recalled products
The agency is working to confirm whether AS Medication and Remedy Repack may also distribute valsartan products not affected by the recall, written in an update of July 27th.
Valsartan is commonly used to treat hypertension and heart failure and was the subject of worldwide concern after the discovery of N-nitrosodimethylamine (NDMA), a probably carcinogenic in the human. ) manufactured by Zhejiang Huahai Pharmaceuticals, Linhai, China.
The Chinese news agency, Xinhua, reports that the company "took According to Xinhua report of July 29, the National Drug Administration" reviewed all seven suppliers of the Valsartan API of the country, including Huahai for the needs of the pharmaceutical industry. NDMA, qualified products from the other six manufacturers. "
This is the second medical scandal in China, after a vaccine manufacturer falsified data and sold defective vaccines to children.
While Zhejiang Huahai stopped distributing its API valsartan. "Certain levels of impurity may have been in products containing valsartan for four years," said the FDA.
"FDA scientists estimate that if 8000 people took the highest dose of valsartan (320 mg) "The batches recalled daily during the full four years, there may be an additional case of cancer during the life of these 8,000 people.This evaluation led to the decision of the FDA to remember these lots, "writes the agency
drugs containing valsartan provided by the Chinese manufacturer on July 5, followed by a voluntary recall from Health Canada on July 9 and from the FDA on July 13.
In its latest bulletin, the FDA lists six other repackaging companies. remember or should remember products containing valsartan. "These are:
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Bryant Ranch Prepack Inc.
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HJ Harkins Co. (this company was originally not listed on the recalled or recalled product lists);
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Lake Erie Medical, doing business under the name of Quality Care Products LLC
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NuCare Pharmaceuticals Inc.
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Northwind Pharmaceuticals and
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ProficientRx.
"The FDA is working to gather information on product recalls from these companies and removed them from the list of products that are not affected by this recall, "notes the agency in the update of July 27.]" It is possible that all products containing valsartan reconditioned by these companies are not affected by the recall, "the statement added.
The agency will update the list of products being recalled and the list of products not currently recalled as more information will be available. [19659018] More information on valsartan reminders is available on the FDA website. Follow Patrice Wendling on Twitter: @pwendl . For more from theheart.org | Medscape Cardiology, follow us on Twitter and Facebook
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