Eptifibatide injection 20mg/10mL — Class III drug recall D-0556-2024
Ongoing recall by Eugia US LLC, reported 2024-06-26, distributed nationwide. Failed Impurities/Degradation Specifications: failed related substance identified as Eptifibatide dimer.
| Recall number | D-0556-2024 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Eugia US LLC, East Windsor, NJ, United States |
| Recall initiated | 2024-05-22 |
| Classified | 2024-06-14 |
| Reported by FDA | 2024-06-26 |
| Distributed | Nationwide (US) |
| Quantity | 15,500 single |
| Reason classes | specification failure |
| NDC | 55150-0218, 55150-0218-99, 55150-0219, 55150-0219-10, 55150-0220, 55150-0220-99 |
| Lot numbers | 3EF22003 |
| Expiration dates | 2025-06-30 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0556-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.