NDC 65174-270
Draximage Maa 2.5 mg injection, powder, 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 | Serious problems, FDA actionNov 3, 2025 · 10 inspections, 4 with FDA action |
Recalls
- Jun 16, 2022 · Class II · Jubilant Draximage Inc
Lack of Assurance of Sterility: Out-of-specification test results obtained for Endotoxin testing.
Lots: Lot # 1H005, exp. date Nov 30, 2023
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Albumin Aggregated: every company that makes it
- Form
- injection, powder, for solution, intravenous
- Strength
- 2.5 mg
- Approval
- BLA BLA017881
- On the market since
- Dec 30, 1987
- Package NDCs
65174-270-30- Official label
- DailyMed (National Library of Medicine), updated Feb 13, 2024
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