Irbesartan Bulk Active Pharmaceutical Ingredient. Supply Disruption — Aurobindo Pharma Limited (Unit I) (Moderate Risk — Temporary
Irbesartan Bulk Active Pharmaceutical Ingredient. Supply Disruption — Aurobindo Pharma Limited (Unit I) (Moderate Risk — Temporary is one of 9,000 drug supply records in the DrugSupply dataset. Key details — Drug name: Irbesartan Bulk Active Pharmaceutical Ingredient.; Manufacturer: Aurobindo Pharma Limited (Unit I); R
| Drug name | Irbesartan Bulk Active Pharmaceutical Ingredient. |
|---|---|
| Manufacturer | Aurobindo Pharma Limited (Unit I) |
| Recall/Disruption reason | CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient. |
| Risk classification | Moderate Risk — Temporary Health Consequence |
| Status | Terminated |
| Record type | Enforcement/Recall |
| Recall number | D-0127-2019 |
| Initiation date | 20181024 |
| Quantity affected | 1724.8 kgs. |
| Dosage form | Drugs |
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