Eugia US LLC recalls Eptifibatide injection 20mg/10mL (2mg/mL), 10mL Single-Dose Vial, Rx only, Mfd. In India for: AuroMedics Pharma, LLC, E.
Recalled June 26, 2024 · FDA recall D-0556-2024 · Eugia US
Hazard
Failed Impurities/Degradation Specifications: failed related substance identified as Eptifibatide dimer. · FDA Class III
Units
15,500 single dose vials
Sold at
USA nationwide.
Description
Failed Impurities/Degradation Specifications: failed related substance identified as Eptifibatide dimer.
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
Manufacturer(s)
Eugia US LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →