The substance is N-nitrosodiethylamine, and the medications recalled were found to have above the acceptable daily intake levels released by the Food and Drug Administration. As The AJC previously reported, the impurity, typically found in certain foods, drinking water and air pollution, has been classified as a human carcinogen by the International Agency for Research on Cancer.
Irbesartan and Irbesartan HCTZ are used to control high blood pressure and for the treatment of heart failure. Irbesartan in combination with amlodipine plus hydrochlorothiazide is used to control high blood pressure, the release states.
The FDA said that patients who have experienced any issues with the recall medication to contact their doctor. Patients should also contact either their doctor or pharmacist for alternative treatments, but to continue using the medication until they get direction from medical experts because stopping it could be a higher risk to their health than N-nitrosodiethylamine, according to the FDA.
This recall is the latest in the past few months. Since July, the FDA has announced voluntary recalls from Major Pharmaceuticals, Solco Healthcare, Teva Pharmaceuticals Industries and Mylan Pharmaceuticals.
In November, Teva Pharmaceuticals voluntarily recalled the Amlodipine/valsartan and amlodipine/valsartan/hydrochlorothiazide combination tablets.
The Biggest Product Recalls in US History
Cox Media Group’s National Content Desk contributed to this report.