NDC 65174-288
Draximage Dtpa 20 mg injection, powder, lyophilized, for solution
On the label: Jubilant DraxImage Inc., dba Jubilant Radiopharma.
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Jubilant HollisterStier General Partnership | Kirkland, Canada | Makes it, tests it and packages it | Serious problems, FDA actionNov 3, 2025 · 10 inspections, 4 with FDA action |
| Jubilant DraxImage Inc., dba Jubilant Radiopharma | Kirkland, Canada | Tests it | Problems found, fixed voluntarilyApr 23, 2024 · 5 inspections |
Recalls
- Mar 19, 2020 · Class II · Jubilant Draximage Inc
Failed Stability Specifications
Lots: Lot # 8K143, Exp 10/31/2020.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Pentetic Acid: every company that makes it
- Form
- injection, powder, lyophilized, for solution, intravenous; respiratory (inhalation)
- Strength
- 20 mg
- Approval
- NDA NDA018511
- On the market since
- Dec 29, 1989
- Package NDCs
65174-288-30- Official label
- DailyMed (National Library of Medicine), updated May 8, 2023
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