FDA Recalls Hypertension Drug Irbesartan

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The recalls and returns will be managed by the respective distributors separately, according to a press release from the company.

Officials with ScieGen Pharmaceuticals, Inc. are voluntarily recalling listed lots, within expiry, of a type of hypertension medication known as Irbesartan Tablets, USP 75 mg, 150 mg, and 300 mg dosage forms to the consumer level due to an impurity.

The impurity, N-nitrosodiethylamine (NDEA) contained in the API Irbesartan, USP manufactured by Aurobindo Pharma Limited, "is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes," according ot a statement from ScieGen Pharmaceuticals, but "has been classified as a 'probable human carcinogen as per International Agency for Research on Cancer (IARC)'."

To date, Sciegen Pharmaceuticals Inc has not received any reports of adverse events related to this product.

The recalls and returns will be managed by the respective distributors separately, according to a press release from the company.

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