EAST WINDSOR, NJ. – A pharmaceutical company has issued a voluntary recall of a drug used for blood pressure because it may contain a cancer-causing impurity.
The recall was issued by Aurobindo Pharma USA, Inc. According to the U.S. Food and Drug Administration 80 lots of Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP, and Valsartan Tablets USP are subject to the recall. The expiration dates on the products range from May 2019 to March 2021.
Officials say the impurity detected in the finished products is N-nitrosodiethylamine or NDEA. The impurity is a substance that occurs naturally in certain foods, water, air pollution, and industrial processes. NDEA has been classified as a probable human carcinogen by the International Agency of Research on Cancer.
To date, Aurobindo Pharma USA, Inc. hasn’t received any reports of adverse events related to the recall.
Click here to see the full list of recalled products.