FDA-Drug2018-11-07Class II
Irbesartan Bulk Active Pharmaceutical Ingredient.
Aurobindo Pharma Limited (Unit I)
Hazard
CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient.
Sold states
Product was distributed to one customer in NY.
Affected count
1724.8 kgs.
Manufactured in
385 386 Bulk Active Plant, Unit I; Survey 379, Arutla, N/A, India
Products
Irbesartan Bulk Active Pharmaceutical Ingredient.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0127-2019Don't want to check this manually?
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