NDC 0338-1055
Metronidazole 500 mg per 100 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
- Jan 21, 2016 · Class I · Baxter Healthcare Corp.
Presence of Particulate Matter: identified as a cloth fiber.
Lots: Lot #: P339135, Exp 08/31/2017 - May 21, 2013 · Class II · Baxter Healthcare Corp.
Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufacturing issue which occurred during the sealing of the closure assembly at the administration port.
Lots: Lot #: P280123, P280123A, Exp 2/14
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Metronidazole: every company that makes it
- Form
- injection, solution, intravenous
- Strength
- 500 mg per 100 mL
- Approval
- NDA NDA018657
- On the market since
- Dec 24, 1981
- Package NDCs
0338-1055-48- Official label
- DailyMed (National Library of Medicine), updated Jun 12, 2025
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