Class III
Drug Recall: 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
Eugia US LLC · May 22, 2024
Reason for Recall
Failed Impurities/Degradation Specifications: failed related substance identified as Eptifibatide dimer.
Distribution
USA nationwide.
States Affected
NATIONWIDE
Quantity Affected
15,500 single dose vials
Source: FDA (openFDA Drug Enforcement)
Recall number: D-0556-2024
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.