Recall: D-0556-2024

Class III - Minor Violations

Class IIIClassification

2024-05-22Initiated

OngoingStatus

Eugia US LLCFirm

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

Failed Impurities/Degradation Specifications: failed related substance identified as Eptifibatide dimer.

Distribution

USA nationwide.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.