FDAFDA · Food and drugs·Recall number 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
Published June 26, 2024 · Recall initiated: May 22, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradation Specifications: failed related substance identified as Eptifibatide dimer.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- EPTIFIBATIDE
- Manufacturer
- Eugia US LLC
- Distributor
- USA nationwide.
- UPC
- 0355150220991
- Lot
- Lot #: 3EF22003, Exp 6/30/2025
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.