FDARecalled Jun 26, 2024 · #D-0556-2024
Eptifibatide injection 20mg/10mL (2mg/mL), 10mL Single-Dose Vial, Rx only, Mfd. In India for: AuroMedics Pharma, LLC, E. Windsor, NJ 08520, NDC 55150-219-10
Hazard
Class III — low health risk
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Failed Impurities/Degradation Specifications: failed related substance identified as Eptifibatide dimer. Classification: Class III Distribution: USA nationwide.
Product details
- Product
- Eptifibatide injection 20mg/10mL (2mg/mL), 10mL Single-Dose Vial, Rx only, Mfd. In India for: AuroMedics Pharma, LLC, E. Windsor, NJ 08520, NDC 55150-219-10
- Type
- Drugs
- Manufacturer
- Eugia US LLC
- Model numbers
- 3EF22003
- UPCs
- —