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FDA testing has found an additional impurity, N-Nitrosodiethylamine, in the API valsartan.
FDA announced on Sept. 13, 2018 that an additional impurity, N-Nitrosodiethylamine (NDEA), has been found in the API valsartan after FDA testing of recalled products by Torrent Pharmaceuticals. NDEA, according to FDA, is a known carcinogen. Products containing valsartan have been recalled after the impurity N-Nitrosodimethylamine (NDMA) was discovered in the API.
Zhejiang Huahai Pharmaceuticals (ZHP) found NDEA in batches of its valsartan API, which prompted FDA to retest all valsartan API and products that contain the API. The testing found NDEA in some of ZHP’s valsartan API and in Torrent’s valsartan 160mg (lot BV47D001) and 320mg (lots BV48D001 and BV48D002) tablets, which were made using API from ZHP. However, the agency says, not all products made using ZHP valsartan API contain the NDEA impurity.
“As we continue to investigate the root cause of the impurities found in products that contain valsartan, our scientists are testing these products to better understand these impurities and to ensure they’re not present in other products. We’re also taking steps to make sure we’re providing stringent oversight of manufacturing processes to reduce the likelihood that impurities could be introduced into other products,” said FDA Commissioner Scott Gottlieb, MD, in a press release. “As we expand our investigational efforts, we’ll continue to make sure the public has the most up-to-date information. We’ll also continue to work with global regulatory agencies to learn as much as we can about how these impurities came about and how they may affect patients’ health around the globe.”
The agency anticipates its risk assessment will be completed in the “coming days.” Should further testing find products containing NDEA or any related impurities, the agency plans to work with companies to remove any affected products from the market.