The 29 lots of single and 51 lots of combination Valsartan medicines distributed under the Actavis label in the US are being recalled due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceutical. Not all valsartan-containing medicines distributed in the United States have valsartan active pharmaceutical ingredient (API) supplied by this specific company.
The U.S. Food and Drug Administration (FDA) has announced a voluntary recall of several blood pressure medications that may contain an impurity known as N-nitrosodimethylamine (NDMA), a probable human carcinogen (a substance that could cause cancer).
Patients taking these prescriptions to treat serious medical conditions should keep taking them until they have a replacement product. In the meantime, the Agency plans to continue its investigation into the possible effects NDMA might have on patients who have been taking these products.
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Valsartan was originally developed by Novartis and the Swiss company marketed it as Diovan, but it is now off patent and is used in a number of generic medicines supplied by various companies. "This is why we've asked these companies to take immediate action to protect patients", said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research.
The ministry revealed that other products that contain the active substance Valsartan manufactured by other companies are safe and are not included in the withdrawal process. The agency also recommends that consumers determine if they are taking a recalled product, find the company-specific recall instructions, and contact their pharmacy and physician. They are also used by patients who have had heart failure or a recent heart attack. The department added that it is in continuous contact with World Health Organization, institutions and other health organization for medicines and pharmaceuticals.
The FDA has said it will "continue to investigate this issue and provide additional information when it becomes available". It can also be unintentionally produced through certain chemical reactions and is a byproduct from some pesticide manufacturing, the making of rubber tires or fish processing.
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Don't stop using the medication if you are affected by the recall.
This recall is being conducted with the full knowledge of the U.S. FDA.
Heath experts warn patients using valsartan to check their bottle to identify its manufacturer.
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