FDA recall D-0556-2024

Eugia US LLC · Class III · drug

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.

Distribution

USA nationwide.

Key facts

Status: Ongoing
Initiation date: 2024-05-22
Report date: 2024-06-26
Voluntary/Mandated: Voluntary: Firm initiated
Location: East Windsor, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0556-2024