AurobindoPharma USA, Inc. is conducting a voluntary recall growth of 38 lots of Valsartan and Amlodipine and Valsartan pills to the consumer level as a result of detection of trace amounts of an abrupt impurity found in the final drug product. This recall is an expansion of the recall initiated 12/31/18 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. The growth relates to a lot distributed under the labels for AurobindoPharma USA, Inc. and Acetris Health, LLC. Up to now, AurobindoPharma USA, Inc. hasn’t received any reports of adverse events associated with this recall.
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