CRANBURY, NJ (WKRN) – Irbesartan and Irbesartan HCTZ tablets are withdrawn by Prinston Pharmaceutical, Inc.
The voluntary recall comes after trace amounts of N-nitrosodiethylamine (NDEA) have been found in pills. NDEA is associated with cancer.
These drugs are used to control high blood pressure and treat heart failure.
There are 7 lots of Irbesartan HCTZ involved in the recall. Click here for the complete list.
According to a press release from the company published on the FDA website, NDEA occurs naturally in some foods, drinking water, air pollution and industrial processes. It has been classified as a likely human carcinogen by the International Cancer Research Agency.
Patients taking Irbesartan and Irbesartan Hydrochlorothiazide should contact their doctor or pharmacist for alternative treatment.
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