The maker of irbesartan, a medicine that treats high blood pressure, is recalling three dosage forms of the tablets because they contain a possibly cancer-causing substance, the Food and Drug Administration says.
ScieGen Pharmaceuticals Inc. issued a voluntary recall of irbesartan in 75 mg, 150 mg and 300 mg doses labeled by Westminster Pharmaceuticals and Golden State medical Supply Inc., the FDA says.
Officials are urging patients to consult their doctors, even if they believe their tablets are on the recall list, saying it’s unsafe to suddenly stop taking the medicine. High blood pressure can damage blood vessels to the heart, brain and kidneys, which can lead to a stroke, heart failure or kidney failure.
Testing shows the tablets contain an impurity called N-nitrosodiethylamine (NDEA), which the International Agency for Research on Cancer has classified as a probable human carcinogen, the FDA says. The impurity also occurs naturally in some foods, drinking water, air pollution and industrial processes.
The tablets in question come in 30-count and 90-count bottles.
FDA website’s recall section lists the lot numbers of 10 dosage forms sent to Westminster and 27 sent to Golden State.
It’s the second recall of a blood pressure medicine since July, when the FDA issued a voluntary recall of valsartan, a blood pressure medicine that also contains NDEA. Two of the five medicines recalled contained hydrochlorothiazide, or HCTZ, a common component in other types of blood pressure medicines.