Prinston Pharmaceuticals has recalled one lot of Irbesartan and seven lots of Irbesartan HCTZ, the company announced in a news release. The medications are used to control high blood pressure and heart failure.
The recall is sparked by “the detection of trace amount of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceuticals,” the news release states.
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.
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 has voluntarily recalled the Amlodipine/valsartan and amlodipine/valsartan/hydrochlorothiazide combination tablets.
See the recall notice here.
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