Tainted valsartan has been on the market for 4 years, FDA discovers
August 7, 2018
By Neozene

China’s Zhejiang Huahai Pharmaceutical set off a global recall after it informed global regulators last month that it had discovered the suspected cancer causing impurity N-nitrosodimethylamine in its valsartan API after changing its manufacturing process. But the FDA is now reporting that the tainted ingredient may have been on the market for years, not weeks or months. The FDA in its most recent update said it wanted to “put some context around the actual potential risk posed to patients” from the levels of N-nitrosodimethylamine (NDMA) found in the products. “Based

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