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.
Product description
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
Lot numbers, UPCs & expiration codes
Lot #: 3TF24002A, Exp 11/30/2026
Where it was sold
USA nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0389-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Apr 21, 2025
- FDA report date
- May 7, 2025
- Quantity
- 18,867 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Eugia US LLC
Original FDA data
Every field from FDA enforcement report D-0389-2025, exactly as published.
Show all FDA fields
- City
- East Windsor
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 96718
- Address
- 279 Princeton Hightstown Rd
- Code information
- Lot #: 3TF24002A, Exp 11/30/2026
- Postal code
- 08520-1401
- Report date
- May 7, 2025
- Product type
- Drugs
- Recall number
- D-0389-2025
- Classification
- Class II
- Recalling firm
- Eugia US LLC
- Product quantity
- 18,867 bags
- Reason for recall
- Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- USA nationwide.
- Recall initiation date
- Apr 21, 2025
- Initial firm notification
- Letter
- Center classification date
- Apr 25, 2025