Eptifibatide Injection
FDA Recall NDC 55150-220
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Eptifibatide (NDC 55150-220). A significant event, classified as Class III, was initiated on May 22, 2024 by Eugia Us Llc. The reported reason for this action was: "Failed Impurities/Degradation Specifications: failed related substance identified as Eptifibatide dimer."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class III Ongoing
Failed Impurities/Degradation Specifications: failed related substance identified as Eptifibatide dimer.
May 22, 2024
Jun 26, 2024
15,500 single dose vials
Recall Profile & Regulatory Data
Event ID
94680
Classification
Class III
Enforcement Status
Ongoing
Recalling Firm
Eugia US LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA nationwide.
Product Description
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
Batch or Lot Expiration Information
Lot# : 3EF22003, Exp 6/30/2025
Affected Packages Involved in this Recall
55150-218-99Product
55150-219-10Product
55150-220-99Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
