Medications & Supplements/Prescription Drugs

Eptifibatide Injection Recalled for Impurity Specifications

Agency Publication Date: June 14, 2024

Summary

Eugia US LLC is recalling 15,500 single dose vials of Eptifibatide injection 20mg/10mL (2mg/mL). This medication is being recalled because it failed testing for impurities and degradation, specifically showing levels of a substance called Eptifibatide dimer that were outside of acceptable limits. This product is a prescription-only injectable medication manufactured in India for AuroMedics Pharma, LLC.

Risk

The presence of impurities or degradation products like Eptifibatide dimer in an injectable medication may pose a health risk to patients or reduce the effectiveness of the treatment.

What You Should Do

This recall affects 10mL single-dose vials of Eptifibatide injection 20mg/10mL (2mg/mL) sold under the AuroMedics Pharma, LLC label (NDC 55150-219-10). The affected medication is identified by lot number 3EF22003 with an expiration date of June 30, 2025.
Stop using the recalled product immediately. Hospital staff, wholesalers, and healthcare providers should quarantine any remaining inventory from the affected lot to ensure it is not administered to patients.
Contact the manufacturer, Eugia US LLC, or your wholesale distributor to arrange for the return of the recalled vials.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional information or to report any adverse events.

Your Remedy Options

Other Action

Quarantine and return of clinical stock.

How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: Eptifibatide injection 20mg/10mL (2mg/mL)

Variants: 10mL Single-Dose Vial, Rx only

Lot Numbers:

3EF22003 (Exp 6/30/2025)

NDC:

55150-219-10

Manufactured in India for AuroMedics Pharma, LLC, East Windsor, NJ.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 94680

Status: Active

Manufacturer: Eugia US LLC

Sold By: AuroMedics Pharma, LLC; Eugia US LLC; Wholesalers

Manufactured In: India

Units Affected: 15,500 single dose vials

Distributed To: Nationwide

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects 10mL single-dose vials of Eptifibatide injection 20mg/10mL (2mg/mL) sold under the AuroMedics Pharma, LLC label (NDC 55150-219-10). The affected medication is identified by lot number 3EF22003 with an expiration date of June 30, 2025.

Stop using the recalled product immediately. Hospital staff, wholesalers, and healthcare providers should quarantine any remaining inventory from the affected lot to ensure it is not administered to patients.

Contact the manufacturer, Eugia US LLC, or your wholesale distributor to arrange for the return of the recalled vials.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional information or to report any adverse events.