Drug 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
D-0556-2024
Product summary
- Firm
- Eugia US LLC
- Event
- Event 94680
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 15,500 single dose vials
- Official record key
drug-enforcement:D-0556-2024
Official wording
Reason: Failed Impurities/Degradation Specifications: failed related substance identified as Eptifibatide dimer.
Code information: Lot #: 3EF22003, Exp 6/30/2025
Distribution pattern: USA nationwide.
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications