Aurobindo Pharma Limited Issues Voluntary Recall of Irbesartan Drug Substance due to the Detection of Trace Amounts of N

Budget101 Discussion List Archives Recalls Aurobindo Pharma Limited Issues Voluntary Recall of Irbesartan Drug Substance due to the Detection of Trace Amounts of N

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      Aurobindo Pharma Limited is voluntarily recalling 22 Batches of the drug substance Irbesartandue to the presence of an impurity, N-nitrosodiethylamine (ndea). the impurity, which is asubstance that occurs naturally in certain foods, drinking water, air pollution, and industrialprocesses, has been classified as a probable human carcinogen as per international agency forresearch on cancer (iarc).

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Budget101 Discussion List Archives Recalls Aurobindo Pharma Limited Issues Voluntary Recall of Irbesartan Drug Substance due to the Detection of Trace Amounts of N