Abstract
Over the past eight months, more than a dozen companies around the world have voluntarily recalled hundreds of batches of generic versions of the drug valsartan, and related products losartan and irbesartan, commonly prescribed to treat high blood pressure and heart failure. The most recent recall occurred earlier this month.According to the Agency for Healthcare Research and Quality, about 1.6 million people purchased valsartan in the US in 2016. The recalled products contained active pharmaceutical ingredients (APIs) with trace amounts of either N-nitrosodimethylamine (NDMA) or N-nitrosodiethylamine (NDEA), which are both probable human carcinogens. Testing by companies and the US Food and Drug Administration has revealed that the impurities came from multiple API manufacturers, facilities that synthesize valsartan and related sartan molecules and then sell them to companies that make the final tablets that reach consumers. Information about how one of these API manufacturers produces valsartan has led ...
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