NDC 65174-461
Sodium Iodide I 131 Diagnostic 100 mCi capsule
On the label: Jubilant DraxImage Inc., dba Jubilant Radiopharma.
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Jubilant DraxImage Inc., dba Jubilant Radiopharma | Kirkland, Canada | Makes it | Problems found, fixed voluntarilyApr 23, 2024 · 5 inspections |
Recalls
- Mar 11, 2016 · Class III · Jubilant Draximage Inc
Labeling: Label Error on Declared Strength
Lots: Lot Number 1670123; Exp 04/16
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Iodide Ion I-131: every company that makes it
- Form
- capsule, oral
- Strength
- 100 mCi
- Approval
- NDA NDA021305
- On the market since
- May 1, 2006
- Package NDCs
65174-461-05- Official label
- DailyMed (National Library of Medicine), updated Aug 25, 2020
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