FDAFDA · Food and drugs·Recall number D-0389-2025
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
Published May 7, 2025 · Recall initiated: April 21, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- TIROFIBAN
- Manufacturer
- Eugia US LLC
- Distributor
- USA nationwide.
- UPC
- 0355150430017
- Lot
- Lot #: 3TF24002A, Exp 11/30/2026
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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