NDC 55150-188
Tranexamic Acid 100 mg per 1 mL injection, solution
On the label: AuroMedics Pharma LLC.
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
- Sep 26, 2022 · Class III · AuroMedics Pharma LLC
Presence of Particulate Matter: Piece of metal found in a vial
Lots: Lot: CTA210006, Exp. 02/2024
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Tranexamic Acid: every company that makes it
- Form
- injection, solution, intravenous
- Strength
- 100 mg per 1 mL
- Approval
- ANDA ANDA205035
- On the market since
- Jan 14, 2016
- Package NDCs
55150-188-10- Official label
- DailyMed (National Library of Medicine), updated Oct 15, 2026
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