Recalls / Class III
Class IIID-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
- Brand name
- Eptifibatide
- Generic name
- Eptifibatide
- Active ingredient
- Eptifibatide
- Route
- Intravenous
- NDCs
- 55150-218, 55150-219, 55150-220
- FDA application
- ANDA206127
- Affected lot / code info
- Lot #: 3EF22003, Exp 6/30/2025
Why it was recalled
Failed Impurities/Degradation Specifications: failed related substance identified as Eptifibatide dimer.
Recalling firm
- Firm
- Eugia US LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 279 Princeton Hightstown Rd, N/A, East Windsor, New Jersey 08520-1401
Distribution
- Quantity
- 15,500 single dose vials
- Distribution pattern
- USA nationwide.
Timeline
- Recall initiated
- 2024-05-22
- FDA classified
- 2024-06-14
- Posted by FDA
- 2024-06-26
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0556-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.