Aurobindo Pharma Limited (Unit I) recalls Irbesartan Bulk Active Pharmaceutical Ingredient.
Recalled November 7, 2018 · FDA recall D-0127-2019 · Aurobindo Pharma Limited (Unit I)
Hazard
CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient. · FDA Class II
Units
1724.8 kgs.
Sold at
Product was distributed to one customer in NY.
Description
CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient.
Product
Irbesartan Bulk Active Pharmaceutical Ingredient.
Manufacturer(s)
Aurobindo Pharma Limited (Unit I)
Made in
India
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →