Eugia US LLC: Drug Recall

Recall #D-0389-2025 · 04/21/2025

Class II: Risk

Recall Details

Recall Number: D-0389-2025
Classification: Class II
Product Type: Drug
Recalling Firm: Eugia US LLC
Status: Ongoing
Date Initiated: 04/21/2025
Location: East Windsor, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 18,867 bags

Reason for Recall

Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.

Product Description

Tirofiban Hydrochloride Injection 5 mg/100 mL (50 mcg/mL), 100 mL single-dose container (bag), Rx only, Manufactured in India for: Eugia U.S. LLC, 279 Princeton-Hightstown Rd., E. Windsor, NJ 08520, NDC 55150-429-01

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 04/10/2025

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.
Class II: Risk 12/18/2024

CGMP Deviations

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.