On Oct. 30, the U.S. Food and Drug Administration (FDA) announced a voluntary recall by ScieGen Pharmaceuticals, Inc. for several lots of irbesartan in USP 75 mg, 150 mg and 300 mg tablets. These products are being recalled due to the presence of N-nitrosodiethylamine (NDEA), an impurity classified as a probable human carcinogen by the International Agency for Research on Cancer.

The irbesartan tablets (USP 75 mg, 150 mg and 300 mg) subject to recall are labeled as Westminster Pharmaceuticals and Golden State Medical Supply, Inc. and are packed in 30-count and 90-count bottles. Review a list of the recalled lot numbers here. To date, ScieGen Pharmaceuticals has not received any reports of adverse events related to this product.

Earlier this year, FDA announced a series of recalls for several drugs containing the active ingredient valsartan due to contamination with a probable carcinogen. The ACC is closely monitoring these recalls and will continue provide members with all available information as the situation develops.

Keywords: ACC Advocacy, Diethylnitrosamine, United States Food and Drug Administration, Carcinogens, Drug Contamination

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