AurobindoPharma USA, Inc. Initiates a Voluntary Nationwide Consumer Level Recall Expansion of 38 Lots of Amlodipine Valsartan Tablets USP and Valsartan Tablets, USP due to the detection of NDEA (N-Nitrosodiethylamine) Impurity.

FDA Suspends Routine Food Inspections Due to the COVID-19 Pandemic Outbreak
FDA Creates New Blueprint for Food Safety Protocol

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.

Source link


Please enter your comment!
Please enter your name here