FDA Drug recall D-0556-2024
Eptifibatide injection 20mg/10mL (2mg/mL), 10mL Single-Dose Vial, Rx only, Mfd
- FDA Drug
- Class III
- ongoing
- Published 2024-06-26
On 2024-06-26 the FDA classified a Class III recall of Eptifibatide injection 20mg/10mL (2mg/mL), 10mL Single-Dose Vial, Rx only, Mfd by Eugia Us, citing failed Impurities/Degradation Specifications: failed related substance identified as Eptifibatide dimer.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0556-2024 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2024-05-22 |
| Published | 2024-06-26 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Eugia Us |
| Distribution | US |
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.
Identifiers
| ndc | 55150-218-99 |
|---|---|
| ndc | 55150-219-10 |
| ndc | 55150-220-99 |
| code_info | Lot #: 3EF22003, Exp 6/30/2025 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0556-2024%22
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