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Unexpected Impurity in Some Valsartan Products

FDA says its latest testing of products with the active pharmaceutical ingredient (API) valsartan shows an additional unexpected impurity in three lots of Torrent Pharmaceuticals’ recalled products. An agency news release says that the second impurity, N-Nitrosodiethylamine (NDEA), is a known animal and suspected human carcinogen.

The release also says that FDA and the European Medicines Agency have learned that Zhejiang Huahai Pharmaceuticals found NDEA in several batches of valsartan API. FDA says it immediately began retesting all valsartan API and products, including both recalled products and those currently marketed in the U.S. for NDEA. It found NDEA in some of Zhejiang’s API and in Torrent lots that were made from Zhejiang API.

“FDA is continuing to test all products that contain valsartan for NDEA and related impurities,” the statement says. “If the agency finds NDEA in products that have not been recalled, FDA will work with companies to ensure all affected products are removed from the market. The agency is also evaluating the risks NDEA in these products poses to patients. FDA expects to complete this risk analysis in the coming days and will continue to provide updates to the public as new information becomes available.”

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