Irbesartan Bulk Active Pharmaceutical Ingredient.
Reported: November 7, 2018 Initiated: October 24, 2018 #D-0127-2019
Product Description
Irbesartan Bulk Active Pharmaceutical Ingredient.
Reason for Recall
CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient.
Details
- Recalling Firm
- Aurobindo Pharma Limited (Unit I)
- Units Affected
- 1724.8 kgs.
- Distribution
- Product was distributed to one customer in NY.
- Location
- Arutla, N/A
Frequently Asked Questions
What product was recalled? ▼
Irbesartan Bulk Active Pharmaceutical Ingredient.. Recalled by Aurobindo Pharma Limited (Unit I). Units affected: 1724.8 kgs..
Why was this product recalled? ▼
CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 7, 2018. Severity: Moderate. Recall number: D-0127-2019.
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