Class III
Ongoing
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
This recall is currently active, issued June 26, 2024. It was issued by Eugia Us Llc.
- Company
- Eugia Us Llc
- Recall Initiated
- May 22, 2024
- Posted
- June 26, 2024
- Recall Number
- D-0556-2024
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 15,500 single dose vials
- Firm Location
- East Windsor, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Failed Impurities/Degradation Specifications: failed related substance identified as Eptifibatide dimer.
Distribution
USA nationwide.
Lot / Code Info
Lot #: 3EF22003, Exp 6/30/2025
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