Why it was recalled
Failed Impurities/Degradation Specifications: failed related substance identified as Eptifibatide dimer.
Product description
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
Lot numbers, UPCs & expiration codes
Lot #: 3EF22003, Exp 6/30/2025
Where it was sold
USA nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0556-2024
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- May 22, 2024
- FDA report date
- Jun 26, 2024
- Quantity
- 15,500 single dose vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Eugia US LLC
Original FDA data
Every field from FDA enforcement report D-0556-2024, exactly as published.
Show all FDA fields
- City
- East Windsor
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 94680
- Address
- 279 Princeton Hightstown Rd
- Code information
- Lot #: 3EF22003, Exp 6/30/2025
- Postal code
- 08520-1401
- Report date
- Jun 26, 2024
- Product type
- Drugs
- Recall number
- D-0556-2024
- Classification
- Class III
- Recalling firm
- Eugia US LLC
- Product quantity
- 15,500 single dose vials
- Reason for recall
- Failed Impurities/Degradation Specifications: failed related substance identified as Eptifibatide dimer.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- USA nationwide.
- Recall initiation date
- May 22, 2024
- Initial firm notification
- Letter
- Center classification date
- Jun 14, 2024