On the possibility that it may cause cancer, Hyderabad based Aurobindo Pharma has started voluntary recall of 22 batches of drug substance Irbesartan from the US market. The Irbesartan, which is used for treating hypertension, has presence of an impurity named N- nitrosodiethylamine (NDEA) that can cause cancer.
The information has been shared by USFDA on its website.
NDEA naturally occurs in industrial process, certain foods, drinking water and air pollution that can cause cancer.
The Irbesartan was being supplied by Aurobindo Pharma to ScieGen Pharmaceuticals, Inc. US, for manufacturing finished Irbesartan drug for the treatment of hypertension.
Aurobindo Pharma has advised ScieGen Pharmaceuticals to get return of identified batches of Irbesartan drug from distributors and retailers.
The USFDA said that ScieGen Pharmaceuticals has also initiated recall of the finished Irbesartan drug from the market.