Reported May 7, 2025 · Ongoing

Tirofiban Hydrochloride Injection 5 mg/100 mL (50 mcg/mL), 100 mL single-dose container (bag), Rx only, Manufactured in…

Eugia US LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Eugia US LLC · 279 Princeton Hightstown Rd · East Windsor, NJ · 08520-1401

Is this the product you have?

  • 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
Lot codes and dates
    • Lot #: 3TF24002A
    • Exp 11/30/2026
Amount recalled
18,867 bags

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

  • Nationwide

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Data as of Sep 19, 8:07 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.