Aurobindo Pharma USA Inc is recalling 80 lots of tablets used for treatment of high blood pressure and heart failure from the American market due to presence of impurity that may cause cancer in humans, the company said.
The voluntary recall of Amlodipine Valsartan tablets USP, Valsartan HCTZ tablets USP and Valsartan tablets USP to the consumer level is due to the detection of trace amounts of an unexpected impurity found in the finished drug product, according to a release by the company posted on the website of the US Food and Drug Administration (USFDA).
"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," it added.
To date, Aurobindo Pharma USA Inc has not received any reports of adverse events related to this recall, the release said.
Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets USP and Valsartan Tablets USP were distributed nationwide to Aurobindo Pharma USA Inc's wholesale, distributor, repackager and retail customers, it added.
The company is notifying its distributors and customers by phone and in writing to immediately discontinue distribution of the specific lots being recalled and to notify their sub-accounts, the release said.
The company is arranging for return of all recalled products to Inmar/CLS Medturn. Instructions for returning recalled products are given in the recall letter, the release added.