Aurobindo Pharma USA, Inc. Initiates Voluntary Nationwide Consumer Level Recall of 80 Lots of Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP and Valsartan Tablets USP, Due to the Detection of NDEA (N-Nitrosodiethylamine) Impurity

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Beef E. coli Outbreak investigation



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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