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Aurobindo Pharma USA, Inc. is conducting a voluntary recall of 80 many Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP and Valsartan Tablets USP into the consumer level as a result of detection of trace quantities of an abrupt impurity located in the final drug product. The impurity found in the final drug product is N-nitrosodiethylamine (NDEA), which is a chemical that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen according to International Agency for Research on Cancer (IARC) classification. So far, Aurobindo Pharma USA, Inc. hasn’t received any reports of adverse incidents associated with the recall.
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FDA Creates New Blueprint for Food Safety Protocol
