Aurobindo Pharma Limited (Unit I) Recall: Irbesartan Bulk Active Pharmaceutical Ingredient
Aurobindo Pharma Limited (Unit I) Recall: Irbesartan Bulk Active Pharmaceutical Ingredient is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Aurobindo Pharma Limited (Unit I); Product: Irbesartan Bulk Active Pharmaceutical Ingredient.; Reason for recall: CGMP Deviation: Presence of NDEA
| Recalling firm | Aurobindo Pharma Limited (Unit I) |
|---|---|
| Product | Irbesartan Bulk Active Pharmaceutical Ingredient. |
| Reason for recall | CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | Product was distributed to one customer in NY. |
| Recall initiated | 20181024 |
| Recall number | D-0127-2019 |
| Category | drug |
| State | N/A |
| Country | India |
$29/mo
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