FDA-Drug2024-06-26Class III
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
Eugia US LLC
Hazard
Failed Impurities/Degradation Specifications: failed related substance identified as Eptifibatide dimer.
Sold states
USA nationwide.
Affected count
15,500 single dose vials
Manufactured in
279 Princeton Hightstown Rd, N/A, East Windsor, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0556-2024Don't want to check this manually?
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