CLASS III ONGOING Drug recall · Reported 26 Jun 2024 · FDA Enforcement Report
Eptifibatide injection 20mg/ (2mg/mL) Single-Dose Vial recalled
Eugia US is recalling Eptifibatide injection 20mg/ (2mg/mL) Single-Dose Vial, distributed nationwide in the US. The recall was initiated on 22 May 2024 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0556-2024
- FDA event ID
- 94680
- Recalling firm
- Eugia US, East Windsor, NJ
- Brand
- Eptifibatide
- Manufacturer
- Eugia US LLC
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 22 May 2024
- FDA classified
- 14 Jun 2024
- Reported
- 26 Jun 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Injectable & IV Drugs
Timeline
| 22 May 2024 | Recall initiated by company | |
| 14 Jun 2024 | Classified by FDA | +23 days |
| 26 Jun 2024 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/Degradation Specifications: failed related substance identified as Eptifibatide dimer.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
USA nationwide.
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications: failed related substance identified as Eptifibatide dimer.
Which lots are affected?
Lot #: 3EF22003, Exp 6/30/2025
Where was it sold?
USA nationwide.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Eugia US
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|---|---|---|---|---|---|
| Drug | CLASS III | Lidocaine HCl Injection, USP 2%, 40 mg recalled by Eugia USLidolog Kit | Eugia US | Other | Nationwide |
| Drug | CLASS II | Gentamicin Injection, USP, (Pediatric), 20 mg recalled by Eugia USGentamicin | Eugia US | Potency & Assay | Nationwide |
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| Drug | CLASS II | Testosterone Cypionate Injection, USP, CIII, 200mg per mL recalledTestosterone Cypionate | Eugia US | Manufacturing (CGMP) Deviations | Nationwide |
Other Eptifibatide recalls
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Eptifibatide Injection, 75 mg/ vial recalledEptifibatide | Slate Run Pharmaceuticals | Other | Nationwide |
| Drug | CLASS III | Eptifibatide Injection, 75 mg/ (0.75 mg/mL) Single-use Vial recalled | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS III | Eptifibatide Injection, a) 20 mg/ (2 mg/mL) Single Use Vial recalled | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS III | Eptifibatide Injection, 75 mg/ (0.75 mg/mL) Single-use Vial recalled | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Eptifibatide Injection 75 mg/ (0.75 mg/mL) single use vial recalled | Teva North America | Manufacturing (CGMP) Deviations | Nationwide |