Aurobindo Pharma Limited (Unit I) recalls

FDA enforcement reports naming Aurobindo Pharma Limited (Unit I) as the recalling firm.

Recall reports: 1
Class I (serious): 0
Most recent report: Nov 7, 2018

Severity

Nov 7, 2018Irbesartan Bulk Active Pharmaceutical IngredientDrug · Aurobindo Pharma Limited (Unit I)CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient.Class II