FDA Recall D-0556-2024
Eugia US LLC · East Windsor, NJ
Class III Ongoing 722 days on record
Lower impact — Class III recall — product violates FDA labeling or manufacturing standards but is unlikely to cause adverse health consequences.
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.
Recall record
- Recall number
D-0556-2024- Classification
- Class III
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- USA nationwide.
- Recall initiated
- 2024-05-22
- Classified by FDA Center
- 2024-06-14
- FDA published
- 2024-06-26
- Recalling firm
- Eugia US LLC
- Firm location
- East Windsor, NJ
Drug identification
- Brand name(s)
- EPTIFIBATIDE
- Generic name(s)
- EPTIFIBATIDE
- Manufacturer(s)
- Eugia US LLC
- NDC(s)
55150-218, 55150-219, 55150-220- Route(s)
- INTRAVENOUS
Operational response
Class III recalls are unlikely to cause adverse health consequences but indicate a violation of FDA labeling or manufacturing standards. Pull from active dispensing per your operational policy.
For the official FDA enforcement record, see FDA's Recall Search.