← DrugSupply
HomeDrug Supply Records

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 nameFomepizole Injection, 1.5 g/1.5 mL (1 g/mL), For Intravenous Infusion only, Rx o
ManufacturerNavinta LLC
Recall/Disruption reasonLack of Assurance of Sterility. A recent FDA inspection reported GMP violations potentially impacting product quality an
Risk classificationModerate Risk — Temporary Health Consequence
StatusTerminated
Record typeEnforcement/Recall
Recall numberD-0431-2015
Initiation date20150309
Quantity affected14,628 units
Dosage formDrugs

🔍 Search all drug supply records →