D-0556-2024 Class III Ongoing
FDA drug recall D-0556-2024 was initiated by Eugia US LLC on May 22, 2024 and is designated Class III. Reason for recall: Failed Impurities/Degradation Specifications: failed related substance identified as Eptifibatide dimer. The recall status is ongoing. Affected quantity: 15,500 single dose vials.
Recall Details
- Product Type
- Drugs
- Report Date
- June 26, 2024
- Initiation Date
- May 22, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 15,500 single dose vials
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
Reason for Recall
Failed Impurities/Degradation Specifications: failed related substance identified as Eptifibatide dimer.
Distribution Pattern
USA nationwide.
Code Information
Lot #: 3EF22003, Exp 6/30/2025