Sciegen Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Irbesartan Tablets, USP 75 Mg, 150 Mg, and 300 Mg Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in The Active Pharmaceutical Ingredient (API)

Defect Levels Handbook

ScieGen Pharmaceuticals, Inc. is voluntarily recalling recorded lots, in expiry, of Irbesartan Tablets, USP 75 milligrams, 150 mg, also 300 mg dose forms to the customer level. These goods are being recalled because of the existence of an impurity,
N-nitrosodiethylamine (NDEA) included at the API Irbesartan, USP made by Aurobindo Pharma Limited. This impurity, that is a chemical that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, has been classified as a probable human carcinogen according to International Agency for Research on Cancer (IARC)

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