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

Recall Number: D-0556-2024

Firm: Eugia US LLC

Classification: Class III

Status: Ongoing

Report Date: 20240626

Initiation Date: 20240522

Termination Date:

Reason for Recall

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