Drug recall D-0556-2024
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
Reason for recall
Failed Impurities/Degradation Specifications: failed related substance identified as Eptifibatide dimer.
Lots and codes
Lot #: 3EF22003, Exp 6/30/2025
Recall details
- Recalling firm
- Eugia US LLC, East Windsor, NJ
- Quantity
- 15,500 single dose vials
- Distribution
- USA nationwide.
- Type
- Voluntary: Firm initiated
- Recall initiated
- May 22, 2024
Related products
- Eptifibatide – drug information
- NDC 55150-218 Eptifibatide · Eptifibatide 75 mg/100mL · Eugia US LLC
- NDC 55150-219 Eptifibatide · Eptifibatide 20 mg/10mL · Eugia US LLC
- NDC 55150-220 Eptifibatide · Eptifibatide 200 mg/100mL · Eugia US LLC