Rx only · Injection, Solution · Intravenous
Iodinated I-131 Albumin
Brands: Megatope · Volumex · Human Serum Albumin I-131
1 ACTIVE SUPPLIER — US
openFDA · updated weekly
US2 NDCs
1 active makers
1 active makers
UKComing
soon
soon
CAComing
soon
soon
AUComing
soon
soon
EUComing
soon
soon
ATC—
RxCUI (US)2674395
US makers1 labelers
Packages2
DEA / ScheduleNone
Medicaid dispensing volume
No Medicaid utilization on record for this drug concept yet. Quarterly volume (CMS State Drug Utilization Data) loads with the utilization ETL.
Who makes it1 active · 0 exited
US labelers as registered with FDA. Repackagers relabel another company's product; share* is of listed packages, not sales.
| Labeler | Type | Packages | Status |
|---|---|---|---|
| Iso-Tex Diagnostics, Inc. | unknown | 2 | SUPPLYING |
Regulatory & supply eventsFDA · US
Shortages, recalls, and registration changes attached to this drug concept.
- Apr 15, 2019RECALLRecall (Class II): Volumex (Iodinated I 131 Albumin) Injection USP, 25 uCi per 1 mL syringe, Rx Only, Manufactured for Daxor Corp., NY, NY…
Lack of Assurance of Sterility: environmental monitoring report exceeds limits, therefore sterility cannot be assured. — Recalling firm: Iso-Tex Diagnostics, Inc — TN
- Mar 11, 2019RECALLRecall (Class II): Volumex (Iodinated I 131 Albumin) Injection USP, 25 uCi per 1 mL syringe, Rx Only, Manufactured for Daxor Corp., NY, NY…
Lack of Assurance of Sterility: preliminary environmental monitoring report exceeds limits, therefore sterility cannot be assured. — Recalling firm: Iso-Tex Diagnostics, Inc — TN
Pill