Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Eugia Pharma Specialities Limited | Sangareddy, India | Makes it, tests it and packages it | Serious problems, FDA actionFeb 6, 2026 · 7 inspections, 2 with FDA action |
Recalls
- Apr 21, 2025 · Class II · Eugia US LLC
Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
Lots: Lot #: 3TF24002A, Exp 11/30/2026 - Apr 21, 2025 · Class II · Eugia US LLC
Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
Lots: Lot# : 3TF24001, Exp 3/31/2026
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Tirofiban: every company that makes it
- Form
- injection, solution, intravenous
- Strength
- 12.5 mg per 250 mL
- Approval
- ANDA ANDA216379
- On the market since
- May 1, 2023
- Package NDCs
55150-430-01- Official label
- DailyMed (National Library of Medicine), updated Jul 13, 2023
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