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

FDA recall notice · announced June 26, 2024 · Eugia Us

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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 for recall

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

Notes

Distribution: USA nationwide.
Lot/code information: Lot #: 3EF22003, Exp 6/30/2025
Quantity: 15,500 single dose vials
Status: Ongoing
Products in this recall event:
- 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 (D-0556-2024)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.