An impurity, N-nitrosodimethylamine (NDMA), which was found in the recalled products, is classified as a probable human carcinogen , a substance that could cause cancer , based on results from laboratory tests. „The FDA is committed to maintaining our gold standard for safety and efficacy. That includes our efforts to ensure the quality of drugs and the safe manner in which they’re manufactured,” said FDA Commissioner Scott Gottlieb, M.D. “When we identify lapses in the quality of drugs and problems with their manufacturing that have the potential to create risks to patients, we’re committed to taking swift action to alert the public and help facilitate the removal of the products from the market.”
The recall was initiated by Prinston Pharmaceutical Inc manufacturer of Valsartan. It is recalling all lots of Valsartan Tablets, 40 mg, 80mg, 160mg, and 320mg; and Valsartan-Hydrochlorothiazide Tablets, 80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg, and 320mg/25mg to the retail level. Prinston Pharmaceutical Inc. has not received any reports of adverse events related to this recall. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this product.