Eptifibatide injection 20mg/10mL (2mg/mL) recall
FDA recall D-0556-2024 · initiated May 22, 2024
Eugia US LLC recalled Eptifibatide injection 20mg/10mL (2mg/mL) in May 2024 — an FDA Class III recall (D-0556-2024) because Failed Impurities/Degradation Specifications: failed related substance identified as Eptifibatide dimer.
Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Why it was recalled
Failed Impurities/Degradation Specifications: failed related substance identified as Eptifibatide dimer.
An impurity above the accepted limit
A by-product of manufacturing or storage exceeded the limit the FDA accepts. Nitrosamines are the common example: the concern is long-term exposure, not immediate danger from one dose.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 15,500 single dose vials
Details
- 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
- Recalling company
- Eugia Pharma
- Classification
- Class III
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- USA nationwide.
- Initiated
- May 22, 2024
- FDA report date
- Jun 26, 2024
Frequently asked
- Was Eptifibatide injection 20mg/10mL (2mg/mL) recalled?
- Eugia US LLC recalled Eptifibatide injection 20mg/10mL (2mg/mL) in May 2024 — an FDA Class III recall (D-0556-2024) because Failed Impurities/Degradation Specifications: failed related substance identified as Eptifibatide dimer. Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
- Why was Eptifibatide injection 20mg/10mL (2mg/mL) recalled?
- Per the FDA enforcement record, the reason for recall D-0556-2024 was: Failed Impurities/Degradation Specifications: failed related substance identified as Eptifibatide dimer.
- Is a recalled Eptifibatide injection 20mg/10mL (2mg/mL) dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Unlikely to cause harm but violates FDA labeling or manufacturing regulations. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Eptifibatide injection 20mg/10mL (2mg/mL) are affected?
- Distributed: USA nationwide.. The recall covers these lots — Lot #: 3EF22003, Exp 6/30/2025. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0556-2024.