Recalls / Class II
Class IID-0389-2025
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 name
- Tirofiban
- Generic name
- Tirofiban
- Active ingredient
- Tirofiban Hydrochloride
- Route
- Intravenous
- NDCs
- 55150-429, 55150-430
- FDA application
- ANDA216379
- Affected lot / code info
- Lot #: 3TF24002A, Exp 11/30/2026
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.
Recalling firm
- Firm
- Eugia US LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 279 Princeton Hightstown Rd, N/A, East Windsor, New Jersey 08520-1401
Distribution
- Quantity
- 18,867 bags
- Distribution pattern
- USA nationwide.
Timeline
- Recall initiated
- 2025-04-21
- FDA classified
- 2025-04-25
- Posted by FDA
- 2025-05-07
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0389-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.