Irbesartan Bulk Active Pharmaceutical Ingredient recalled over manufacturing violations
- Recall date
- October 24, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Aurobindo Pharma Limited (Unit I) recalls Irbesartan Bulk Active Pharmaceutical Ingredient.
- Recall number
- D-0127-2019
- FDA classification
- Class II
- Brand / firm
- Aurobindo Pharma Limited (Unit I)
- Sold / distributed
- Product was distributed to one customer in NY.
Why it was recalled
CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Irbesartan Bulk Active Pharmaceutical Ingredient.
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