NDC 62756-129
Pantoprazole Sodium 40 mg per 10 mL injection, powder, lyophilized, for solution
On the label: Caraco Pharmaceutical Laboratories, Ltd..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Sun Pharmaceutical Industries Limited | Halol, India | Makes it and tests it | Serious problems, FDA actionJun 13, 2025 · 12 inspections, 5 with FDA action |
Recalls
- Feb 5, 2021 · Class III · Sun Pharmaceutical Industries Inc
Failed Impurity/Degradation Specifications
Lots: JKU3595A, JKU3596A, JKU3597A, and JKU3629A; Exp 02/2021
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, powder, lyophilized, for solution, intravenous
- Strength
- 40 mg per 10 mL
- Approval
- ANDA ANDA077674
- On the market since
- Sep 1, 2019
- Package NDCs
62756-129-4062756-129-4462756-129-45- Official label
- DailyMed (National Library of Medicine), updated Jan 22, 2025
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