NDC 0338-9648
Pantoprazole Sodium 80 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 | Round Lake, IL, United States | Makes it, tests it, packages it, labels it and sterilizes it | Serious problems, FDA actionApr 2, 2026 · 15 inspections, 2 with FDA action |
Recalls
- Aug 6, 2026 · Class II · Baxter Healthcare Corporation
CGMP Deviations
Lots: Lot # NC194129, Exp Date: 05/07/2028.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Pantoprazole: every company that makes it
- Form
- injection, solution, intravenous
- Strength
- 80 mg per 100 mL
- Approval
- NDA NDA217512
- On the market since
- Feb 14, 2024
- Package NDCs
0338-9648-010338-9648-12- Official label
- DailyMed (National Library of Medicine), updated Feb 14, 2024
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