NDC 65174-179
Kit for the Preparation of Technetium Tc 99m Sulfur Colloid 18.1 mg per 10 mL kit
On the label: Jubilant DraxImage Inc., dba Jubilant Radiopharma.
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Jubilant HollisterStier LLC | Spokane, WA, United States | Makes it, tests it, packages it and labels it | No problems foundMar 5, 2021 · 13 inspections, 1 with FDA action |
| Jubilant DraxImage Inc., dba Jubilant Radiopharma | Kirkland, Canada | Tests it | Problems found, fixed voluntarilyApr 23, 2024 · 5 inspections |
Recalls
- Nov 22, 2024 · Class II · Jubilant Draximage Inc., dba Jubilant Radiopharma
Failed Stability Specifications
Lots: LOT C2300070 and C2300070E;Exp. May 31, 2025
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Technetium Tc-99m Sulfur Colloid: every company that makes it
- Form
- kit
- Strength
- 18.1 mg per 10 mL
- Approval
- ANDA ANDA213516
- On the market since
- Dec 4, 2023
- Package NDCs
65174-046-0165174-047-0165174-131-0165174-179-01- Official label
- DailyMed (National Library of Medicine), updated Dec 5, 2023
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