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 initiated: 20240522
Status: Ongoing
Classification: Class III
Recall type: Voluntary: Firm initiated