Recalling firm
Eugia US LLC
Product type
Drug
Status
Ongoing
Report date
2024-06-26
Distribution
USA nationwide.
Firm state
NJ
Product quantity
15,500 single dose vials
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & QualificationReason 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
Code / lot info
Lot #: 3EF22003, Exp 6/30/2025
Other recalls SPEQ maps to Validation & Qualification
See all Validation & Qualification recalls →Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.