NDC 55150-203
Vancomycin Hydrochloride 500 mg per 10 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
- Nov 25, 2019 · Class II · AuroMedics Pharma LLC
Discoloration: Product complaints of discoloration after reconstitution of vials.
Lots: Lot #: CVM180003, CVM180004, Exp 04/2020; CVM180008, Exp 07/2020; CVM180009, CVM180010, CVM180011, CVM180012, Exp 09/2020
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Vancomycin: every company that makes it
- Form
- injection, powder, lyophilized, for solution, intravenous
- Strength
- 500 mg per 10 mL
- Approval
- ANDA ANDA205780
- On the market since
- Mar 31, 2016
- Package NDCs
55150-203-10- Official label
- DailyMed (National Library of Medicine), updated Jul 8, 2024
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