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Aurobindo Pharma Limited (Unit I) Recalls

1 recall on record · November 7, 2018 to November 7, 2018 · Drugs

November 7, 2018DrugsFDA

Aurobindo Pharma Limited (Unit I) recalls Irbesartan Bulk Active Pharmaceutical Ingredient.

Hazard: CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient.

Aurobindo Pharma Limited (Unit I) Recalls | RecallWatchUSA