# FDA recall D-0556-2024

> **Eugia US LLC** · Class III · drug recall initiated 2024-05-22.

## 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.

## Distribution

USA nationwide.

## Key facts

- **Recall number:** D-0556-2024
- **Recalling firm:** Eugia US LLC
- **Classification:** Class III
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2024-05-22
- **Report date:** 2024-06-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** East Windsor, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0556-2024

## Citation

> AI Analytics. FDA recall D-0556-2024. Retrieved 2026-07-08 from https://api.ai-analytics.org/recall/D-0556-2024. Source: US FDA. Licensed CC0.

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