FDA recall D-0127-2019
Aurobindo Pharma Limited (Unit I) · Class II · drug
Product
Irbesartan Bulk Active Pharmaceutical Ingredient.
Reason for recall
CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient.
Distribution
Product was distributed to one customer in NY.
Key facts
- Status
- Terminated
- Initiation date
- 2018-10-24
- Report date
- 2018-11-07
- Termination date
- 2020-03-27
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Arutla, N/A, India
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0127-2019