Heart medication recalled after impurity found in ingredient.
Prinston Pharmaceutical Inc., is voluntarily recalling one lot of Irbesartan and seven lots of Irbesartan HCTZ Tablets containing N- nitrosodiethylamine (NDEA).
N-nitrosodiethylamine (NDEA) is classified as a probable human carcinogen, but occurs naturally in certain foods, water, air pollution, and industrial processes.
As of their release on January 18, Prinston Pharmaceutical Inc. says they have not received any reports of adverse events related to this recall.
Irbesartan and Irbesartan HCTZ are used to control high blood pressure and for the treatment of heart failure.
According to Prinston Pharmaceutical Inc., patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication. they should aslos continue taking the medication until a replacement is prescribed.
The product subject to recall can be found by clicking here.