Aurobindo Pharma Limited Issues Voluntary Recall of Irbesartan Drug Substance due to the Detection of Trace Amounts of NDEA (NNitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API)

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Defect Levels Handbook

Aurobindo Pharma Limited is voluntarily recalling 22 Batches of this drug substance Irbesartan
On account of the existence of an impurity, N-nitrosodiethylamine (NDEA). The impurity, that can be a

Procedures, was classified as a probable human carcinogen according to International Agency for
Research on Cancer (IARC).



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