FDAHealthApril 21, 2025
Eugia US LLC — Tirofiban Hydrochloride Injection 12.5 mg/250 mL (50 mcg/mL), 250 mL single-dose container (bag), Rx only, Manufactured in India for: Eugia U.S. LLC, 279 Princeton-Hightstown Rd., E. Wi
⚠️ 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 12.5 mg/250 mL (50 mcg/mL), 250 mL single-dose container (bag), Rx only, Manufactured in India for: Eugia U.S. LLC, 279 Princeton-Hightstown Rd., E. Windsor, NJ 08520, NDC 55150-430-01
- Brand
- TIROFIBAN
- UPC
- 0355150430017
- Lot code
- :
Additional details
Lot# : 3TF24001, Exp 3/31/2026
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated
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