TIROFIBAN
Recalling Firm / Manufacturer: Eugia US LLC
(East Windsor, NJ, United States)
FDA Recall Number: D-0389-2025
Source Authority Disclaimer: This drug recall notice is published by Questo using official enforcement reports issued by the U.S. Food & Drug Administration (FDA). It is provided for informational, academic, and clinical research purposes only. Patients should not discontinue prescribed treatments without consulting their physician or pharmacist.
Product & Identification Information
Brand, active ingredients, NDC codes, and manufacturer details
Brand / Trade Name
TIROFIBAN
Generic Name
TIROFIBAN
Active Substance(s)
Tirofiban Hydrochloride
Administration Route
Intravenous
National Drug Code (NDC)
55150-429
Total Quantity Recalled
18,867 bags
Official Reason for Recall
Specific hazard or quality defect cited by the FDA
According to the official FDA enforcement report:
Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
Full Product Description
Packaging specifications and labeling details
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
Enforcement & Regulatory Details
FDA classification, report dates, and initiation authority
Health Hazard Classification
Class II
Current Action Status
Ongoing
FDA Enforcement Report Date
May 07, 2025
Firm Initiation Date
April 21, 2025
FDA Classification Date
Apr 25, 2025
Initiation Type
Voluntary: Firm initiated
Affected Lots & Batch Numbers
Product codes, lot numbers, and expiration dates
Lot #: 3TF24002A, Exp 11/30/2026
Distribution Information
Geographic scope of affected shipments
USA nationwide.
Safety Guidance & Actions
Standard FDA protocol for patients and healthcare providers
Patient Advisory
Check your prescription bottle or packaging against the affected lot numbers listed above. If your medication matches a recalled lot, contact your pharmacist for replacement guidance.
Healthcare Provider Guidance
Audit pharmacy stock and return affected lots to the distributor per manufacturer instructions. Notify patients where clinically indicated.
Official Source Provenance
Verified regulatory citation from U.S. FDA OpenFDA
Primary Data Source: U.S. Food & Drug Administration (FDA) OpenFDA API
Recall Number: D-0389-2025
Questo Retrieval Date: July 31, 2026 14:36 1785508616UTCC