NDC 0338-6045
Fluconazole 400 mg per 200 mL injection, solution
On the label: Baxter Healthcare Corporation.
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Baxter Healthcare Corporation | Jayuya, PR, United States | Makes it, tests it, packages it, labels it and sterilizes it | Problems found, fixed voluntarilyJul 19, 2024 · 15 inspections, 5 with FDA action |
| Baxter Healthcare Corporation | Round Lake, IL, United States | Tests it | Serious problems, FDA actionApr 2, 2026 · 15 inspections, 2 with FDA action |
Recalls
- May 15, 2017 · Class II · Baxter Healthcare Corporation
Lack of assurance of sterility: customer complaints received for the presence of leaks.
Lots: Lot #: P344028/P344028A, Exp 12/31/17; P352377, Exp 8/31/18; P348136, Exp 4/30/18 - Dec 6, 2016 · Class II · Baxter Healthcare Corporation
Lack of Assurance of Sterility: confirmed customer complaints of leaking bags.
Lots: Lot #: P344028 on bags, P344028A on shipping container, Exp 12/31/2017 - Dec 23, 2014 · Class II · Baxter Healthcare Corp.
Lack of Assurance of Sterility: Complaints of leaks due to an incomplete seal at the bag seam.
Lots: Lot #: P318394; Exp 05/31/16
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Fluconazole: every company that makes it
- Form
- injection, solution, intravenous
- Strength
- 400 mg per 200 mL
- Approval
- ANDA ANDA076766
- On the market since
- Jul 29, 2004
- Package NDCs
0338-6045-37- Official label
- DailyMed (National Library of Medicine), updated Jun 24, 2024
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