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Torrent's Recalled Valsartan Products Contain Not 1 But 2 Probable Carcinogens

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Torrent Pharmaceuticals Ltd.'s recalled Valsartan products have been found to contain a second impurity, N-Nitrosodiethylamine (NDEA), a known animal and suspected human carcinogen. The finding is based on results from FDA tests.

Valsartan is an active pharmaceutical ingredient in drugs used to treat high blood pressure and heart failure. Valsartan is available on its own or in combination with other active substances.

On August 23, 2018, India-based Torrent Pharma recalled all lots of Valsartan products due to the detection of trace amounts of N-nitrosodimethylamine (NDMA), found in an active pharmaceutical ingredient (API) manufactured by Chinese company Zhejiang Huahai Pharmaceuticals. NDMA is also a substance that could cause cancer.

Torrent Pharma is one of the many companies to have recalled the Valsartan products over potential carcinogen contamination. Like N-Nitrosodimethylamine (NDMA), which was found in the recalled Valsartan products, NDEA is also formed from a specific sequence of manufacturing steps and chemical reactions.

Commenting on the FDA tests results, FDA Commissioner Scott Gottlieb, said, " 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."

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Valsartan Drugs Recalled Over Potential Carcinogen Contamination

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