Recalls, Market Withdrawals, & Safety Alerts > 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)

Recalls, Market Withdrawals, & Safety Alerts > 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)

A new MedWatch Safety Alert recall: Irbesartan Drug Substance by Aurobindo Pharma Limited: Recall - Due to the Detection of Trace Amounts of NDEA (NNitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient was just added to the FDA Recalls webpage.

 

You can read the complete recall alert at: https://www.fda.gov/Safety/Recalls/ucm624547.htm