Arutla, N/A, India
Aurobindo Pharma Limited (Unit I) recalls
1 recall recorded since 2018, most recently on 24 October 2018. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Drugs
- Recall started
- 24 October 2018
- Terminated
- 27 March 2020
- Reason
- CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient.
- Distribution
- Product was distributed to one customer in NY.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0127-2019
- Irbesartan Bulk Active Pharmaceutical Ingredient.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.