Eugia US LLC: Drug Recall

Recall #D-0556-2024 · 05/22/2024

Class III: Low Risk

Recall Details

Recall Number: D-0556-2024
Classification: Class III
Product Type: Drug
Recalling Firm: Eugia US LLC
Status: Ongoing
Date Initiated: 05/22/2024
Location: East Windsor, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 15,500 single dose vials

Reason for Recall

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

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

Distribution Pattern

USA nationwide.

Other Recalls by Eugia US LLC

Class II: Risk 05/29/2025

Failed Stability Specifications: Out of specification results for the Color Absorbance test during 12 Month sample analysis.
Class II: Risk 04/21/2025

Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
Class II: Risk 04/21/2025

Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
Class II: Risk 04/10/2025

cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.
Class II: Risk 12/27/2024

Presence of Particulate Matter: A market complaint was received of a glass piece in the vial.

View all recalls by Eugia US LLC →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.