Home | Top News | World | US News | Politics | Economy | Sports | Technology | Science | Lifestyle | People | Recalls

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.

AurobindoPharma USA, Inc. is conducting a voluntary recall expansion of 38 lots of Valsartan and Amlodipine and Valsartan tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in the finished drug product. This recall is an expansion of the recall initiated 12/31/18 The impurity detected in the finished drug product is N-nitrosodiethylamine (NDEA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification. The expansion relates to lots distributed under the labels for AurobindoPharma USA, Inc. and Acetris Health, LLC. To date, AurobindoPharma USA, Inc. has not received any reports of adverse events related to this recall. (US Food Recalls) More More

Similar stories

FDA Provides Update on Tainted ARB Investigation, With New Impurity Found - TCTMD

FDA Provides Update on Tainted ARB Investigation, With New Impurity Found  TCTMD

Recalls continue to roll in as part of the US Food and Drug Administration's investigation into angiotensin II receptor blockers (ARBs)—specifically valsartan, ...

Posted on 4 March 2019 | 3:00 am | Google News

Copyright © 2019 LastMinuteStuff.com
Contact info