Cranbury-based Prinston Pharmaceutical has initiated a voluntary recall of one lot of Irbesartan and seven lots of Irbesartan HCTZ tablets due to the detection of trace amount of an unexpected impurity found in an active ingredient manufactured by Zhejiang Huahai pharmaceuticals.
In a statement Prinston said that it is only recalling lots of Irbesartan containing products that have N-nitrosodiethylamine above the acceptable daily intake levels released by the FDA.
N-nitrosodiethylamine is found in certain foods and drinking water and has been classified as a probable human carcinogen according to the International Agency for Research on Cancer.
To date, Prinston said that it has not received any reports of adverse events related to the recall.
Irbesartan is used to control high blood pressure and for the treatment of heart failure.
The products subject to recall are listed on the company’s web site. http://www.prinstonpharm.com/PDF/PressRelease-IrbesartanRecall.pdf