NDC 55150-234
Polymyxin B 500000 [USP'U] 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
- Jan 26, 2022 · Class I · AuroMedics Pharma LLC
Presence of Particulate Matter; product complaint of hair discovered in a vial within the lot
Lots: Lot CPB200013, exp 9/2022
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Polymyxin B: every company that makes it
- Form
- injection, powder, lyophilized, for solution, intramuscular; intrathecal; intravenous; ophthalmic
- Strength
- 500000 [USP'U]
- Approval
- ANDA ANDA206589
- On the market since
- Apr 4, 2016
- Package NDCs
55150-234-10- Official label
- DailyMed (National Library of Medicine), updated May 9, 2025
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