Irbesartan and Irbesartan/HCTZ Recalled
January 18, 2019 – Prinston Pharmaceutical has voluntarily recalled one lot of Irbesartan Tablets and seven lots of Irbesartan/Hydrochlorothiazide (HCTZ) Tablets. The tablets contain trace amounts of N-nitrosodiethylamine (NDEA) in excess of current FDA limits.
NDEA is considered a probable human carcinogen (cancer-causing agent), and has been the reason for a number of recalls of angiotensin II receptor blockers (ARBs) like irbesartan since mid-2018. The substance occurs naturally in certain foods, drinking water, air pollution, and industrial processes.
Because irbesartan and irbesartan/hctz are used to treat conditions such as heart failure and high blood pressure, patients are advised to continue taking their medication, even if it has been recalled, until they receive a replacement product or have been switched to an alternative therapy by their prescriber. The risk of harm from stopping treatment may outweigh the risks of exposure to NDEA found in the recalled products.
A list of recalled lots and complete instructions for returning recalled products can be found at:
Benecard Central Fill is contacting affected members to notify them of the recall and next steps.