In a valsartan recall update, the FDA has informed consumers that Torrent Pharmaceuticals is voluntarily recalling all lots of its valsartan products in connection with a recent contamination.
On Aug. 23, the U.S. Food and Drug Administration (FDA) made a new valsartan recall update, announcing that Torrent Pharmaceuticals Ltd. initiated a voluntary recall of all of their valsartan tablets due to a potential contamination.
The recent valsartan recall update is the latest news in an ongoing investigation into valsartan contamination. In mid-July, the FDA announced that several companies had initiated a voluntary recall of their valsartan products due to potential contamination.
The source was an unexpected contamination in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceuticals. According to the company, the API was unexpectedly contaminated with trace amounts of N-nitrosodimethylamine (NDMA).
NDMA occurs in air pollution, industrial processes, certain foods, and drinking water. Although NDMA is found naturally, it has been classified as a probable human carcinogen by the International Agency for Research on Cancer (IARC). Because of the danger associated with the chemical, many companies have initiated voluntary recalls of valsartan products potentially contaminated with NDMA.
New information is being released at a rapid pace, prompting the FDA to take an active role in the valsartan recall process and investigation. The agency is supporting both consumers and manufacturers by providing regular valsartan recall updates regarding involved parties and the next steps for consumers.
“The FDA is committed to maintaining our gold standard for safety and efficacy. That includes our efforts to ensure the quality of drugs and the safe manner in which they’re manufactured,” said FDA Commissioner Scott Gottlieb in the agency’s original press release. “When we identify lapses in the quality of drugs and problems with their manufacturing that have the potential to create risks to patients, we’re committed to taking swift action to alert the public and help facilitate the removal of the products from the market. As we seek the removal of certain drug products today, our drug shortages team is also working hard to ensure patients’ therapeutic needs are met in the United States with an adequate supply of unaffected medications.”
To date, companies involved in the valsartan recall include Hetero Labs Limited (labelled as Camber Pharmaceuticals); Teva Pharmaceuticals (labelled as Major Pharmaceuticals and Actavis); Prinston Pharmaceuticals (labelled as Solco Healthcare LLC, A-S Medication Solutions LLC, AvKARE, and RemedyRepack Inc.); Bryant Ranch Prepack Inc.; H. J. Harkins Company Inc.; Lake Erie Medical (doing business as Quality Care Products LLC); NuCare Pharmaceuticals Inc.; Northwind Pharmaceuticals; Proficient Rx; and Torrent Pharmaceuticals Limited.
Legal experts are investigating whether or not consumers have grounds to take action against manufacturers and distributors for potential harm caused by the drug. If you were prescribed and ingested a contaminated valsartan product, you may be eligible to participate in this investigation.
If you developed cancer or severe liver damage after taking valsartan, you may benefit from joining a free valsartan lawsuit investigation. Fill out the FREE form on this page for more information.
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