Drug 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
D-0389-2025
Product summary
- Firm
- Eugia US LLC
- Event
- Event 96718
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 18,867 bags
- Official record key
drug-enforcement:D-0389-2025
Official wording
Reason: Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
Code information: Lot #: 3TF24002A, Exp 11/30/2026
Distribution pattern: USA nationwide.
Derived failure modes
-
Potency or specification failure
Out-of-Specification