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CRANBURY, N.J. (CBS Baltimore) — Prinston Pharmaceutical Inc. has voluntarily recalled one lot of Irbesartan and seven lots of Irbesartan HCTZ Tablets due to a detection of trace amount of an unexpected impurity found in an ingredient.
Prinston is only recalling lots of Irbesartan-containing products that contain Nnitrosodiethylamine (NDEA) above the acceptable daily intake levels released by the FDA.
“N-nitrosodiethylamine (NDEA) is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes and has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification,” the company said in a press release on Jan. 18.
The company has not received any reports of adverse reactions related to the drug.
Irbesartan and Irbesartan HCTZ are used to control high blood pressure and for treatment of heart failure.
Patients should contact their doctors if they were prescribed the drug and get an alternative treatment.
For a full list of the drugs recalled, click here: Irbesartan recall.