NDC 55150-470
Tobramycin 1.2 g per 30 mL injection, powder, lyophilized, for 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
- Feb 22, 2024 · Class II · Eugia US LLC
Failed Stability Specification: Water determination was found not complying with specification.
Lots: Lot #s: 3TB23001, 3TB23002, Exp. 04/30/2025.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Tobramycin: every company that makes it
- Form
- injection, powder, lyophilized, for solution, intravenous
- Strength
- 1.2 g per 30 mL
- Approval
- ANDA ANDA217519
- On the market since
- Jun 21, 2023
- Package NDCs
55150-470-0155150-470-06- Official label
- DailyMed (National Library of Medicine), updated Jul 6, 2024
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