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
Failed Impurities/Degradation Specifications: failed related substance identified as Eptifibatide dimer.
Classification
Class III
Status
Ongoing
Lot
Lot #: 3EF22003, Exp 6/30/2025
Date
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