Irbesartan Bulk Active Pharmaceutical Ingredient.
Recall Number: D-0127-2019
Firm: Aurobindo Pharma Limited (Unit I)
Classification: Class II
Status: Terminated
Report Date: 20181107
Initiation Date: 20181024
Termination Date: 20200327
Reason for Recall
CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient.
Product Description
Irbesartan Bulk Active Pharmaceutical Ingredient.