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Drug FDA Class III Ongoing Failed specifications

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

Eugia US LLC Published Jun 26, 2024

Risk level

Class III

Unlikely to cause harm, but violates labeling or manufacturing rules.

Severity score 40/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Eugia US LLC or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Failed Impurities/Degradation Specifications: failed related substance identified as Eptifibatide dimer.

Hazards

Eptifibatide dimer · primary

Affected products (1)

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

EPTIFIBATIDE · 15,500 single dose vials

NDC: 55150-218, 55150-219, 55150-220, 55150-218-99, 55150-219-10, 55150-220-99
Code info: Lot #: 3EF22003, Exp 6/30/2025

Affected areas

Nationwide

Timeline

  1. Initiated
    May 22, 2024
  2. Published
    Jun 26, 2024
Recall number
D-0556-2024
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.