Fomepizole Injection, 1.5 g/1.5 mL (1 g/mL), For Intravenous Infusion only, Rx o Supply Disruption — Navinta LLC (Moderate Risk —
Fomepizole Injection, 1.5 g/1.5 mL (1 g/mL), For Intravenous Infusion only, Rx o Supply Disruption — Navinta LLC (Moderate Risk — is one of 9,000 drug supply records in the DrugSupply dataset. Key details — Drug name: Fomepizole Injection, 1.5 g/1.5 mL (1 g/mL), For Intravenous Infusion only, Rx o; Manufacturer: Navint
| Drug name | Fomepizole Injection, 1.5 g/1.5 mL (1 g/mL), For Intravenous Infusion only, Rx o |
|---|---|
| Manufacturer | Navinta LLC |
| Recall/Disruption reason | Lack of Assurance of Sterility. A recent FDA inspection reported GMP violations potentially impacting product quality an |
| Risk classification | Moderate Risk — Temporary Health Consequence |
| Status | Terminated |
| Record type | Enforcement/Recall |
| Recall number | D-0431-2015 |
| Initiation date | 20150309 |
| Quantity affected | 14,628 units |
| Dosage form | Drugs |
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