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)

Aurobindo Pharma Limited is voluntarily recalling 22 Batches of the drug substance Irbesartandue to the presence of an impurity, N-nitrosodiethylamine (NDEA).

Source: FDA Center for Drug Evaluation and Research - What's New - June 4, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news