Class IIOngoing

Tirofiban Hydrochloride Injection 5 mg/100 mL (50 mcg/mL) recall

FDA recall D-0389-2025 · initiated Apr 21, 2025

May cause temporary or medically reversible harm; low probability of serious harm.

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.

Details

Product: 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
Recalling company: Eugia Pharma
Classification: Class II
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: USA nationwide.
Initiated: Apr 21, 2025
FDA report date: May 7, 2025

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0389-2025 ↗

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