Drug Recall: Eptifibatide Injection Due to Failed Degradation Specifications
Eugia US LLC is recalling 15,500 vials of Eptifibatide injection nationwide due to failed impurities and degradation specifications. The defect involves a related substance identified as Eptifibatide dimer.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class III recall with no reported illnesses or injuries. The defect is a manufacturing quality issue involving an impurity (degradation product), making this a precautionary recall.
Plain-English summary
Eugia US LLC is recalling 15,500 single-dose vials of Eptifibatide injection 20mg/10mL (2mg/mL) distributed nationwide. The recall affects Lot #3EF22003 with expiration date 6/30/2025.
The recall is being conducted because the affected lot failed impurities and degradation specifications during quality testing. Specifically, a related substance identified as Eptifibatide dimer was detected at levels that exceed acceptable limits.
Healthcare providers and facilities who may have received vials from this lot should verify the lot number and take appropriate action per FDA and manufacturer guidance. Patients who have received this medication should contact their healthcare provider if they have questions regarding this recall.
The recalled product
- Product
- EPTIFIBATIDE (EPTIFIBATIDE)
- Brand
- EPTIFIBATIDE
- Manufacturer
- Eugia US LLC
- Category
- Drug — Injectable / Antiplatelet
- Affected units
- 15,500
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 3EF22003
- Exp 6/30/2025
UPCs (2)
- 0355150220991
- 0355150219100
Distribution
Distributed nationwide across the United States.
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