FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

FDA Discovers Second Impurity in Chinese Manufacturer’s Valsartan

Sept. 17, 2018
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Another impurity has been detected in Zhejiang Huahai Pharmaceuticals’ ill-fated active ingredient valsartan, the FDA announced Thursday.

The FDA said its latest tests showed an unexpected impurity in three lots of Torrent Pharmaceutical’s recalled drug products that contained valsartan manufactured by the Chinese firm — N-nitrosodiethylamine (NDEA). This marks the second impurity that has been found in the manufacturer’s product since the NDMA impurity was detected this summer. Both ingredients are classified as probable human carcinogens, with long-term exposure posing possible cancer risks.

“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,” said FDA Commissioner Scott Gottlieb. “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.”

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