FDAHealthApril 21, 2025
Eugia US LLC — 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. Winds
⚠️ Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- April 21, 2025
USA nationwide.
What's affected?
- 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
- Brand
- TIROFIBAN
- UPC
- 0355150430017
- Lot code
- 3TF24002A
Additional details
Lot #: 3TF24002A, Exp 11/30/2026
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 18,867 bags.
Get Health recall alerts
Delivered to your inbox. Free. No account required.