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
Reported: June 26, 2024 Initiated: May 22, 2024 #D-0556-2024
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
Reason for Recall
Failed Impurities/Degradation Specifications: failed related substance identified as Eptifibatide dimer.
Details
- Recalling Firm
- Eugia US LLC
- Units Affected
- 15,500 single dose vials
- Distribution
- USA nationwide.
- Location
- East Windsor, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Eugia US LLC. Units affected: 15,500 single dose vials.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications: failed related substance identified as Eptifibatide dimer.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 26, 2024. Severity: Low. Recall number: D-0556-2024.
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