NDC 50914-7720
Volumex 0.025 mCi per 1 mL injection, solution
On the label: Iso-Tex Diagnostics, Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Iso-Tex Diagnostics, Inc. | Alvin, TX, United States | Makes it | Serious problems, FDA actionFeb 3, 2026 · 13 inspections, 5 with FDA action |
Recalls
- Apr 15, 2019 · Class II · Iso-Tex Diagnostics, Inc
Lack of Assurance of Sterility: environmental monitoring report exceeds limits, therefore sterility cannot be assured.
Lots: Lot: V191004-927 Exp. 05/10/19 - Mar 11, 2019 · Class II · Iso-Tex Diagnostics, Inc
Lack of Assurance of Sterility: preliminary environmental monitoring report exceeds limits, therefore sterility cannot be assured.
Lots: Lot: V190603-922, Exp. 04/05/19
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Human Serum Albumin I-131: every company that makes it
- Form
- injection, solution, intravenous
- Strength
- 0.025 mCi per 1 mL
- Approval
- BLA BLA017837
- On the market since
- Aug 1, 1993
- Package NDCs
50914-7720-8- Official label
- DailyMed (National Library of Medicine), updated Nov 21, 2022
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