Labeler · US market

Iso-Tex Diagnostics, Inc.

Iso-Tex Diagnostics, Inc. is a US drug labeler with US FDA registrations covering 2 drug concepts (2 currently active) across 3 packages. It is currently the only active US supplier of 2 drugs.

ACTIVE — US

openFDA · updated weekly

Labeler codes50914

Active drugs2

Registrations3 active / 3

Packages3

Sole supplier of2 drugs

Portfolio2 drugs · US

Every drug concept this labeler has US registrations for, by package count.

Drug	Type	NDCs	Packages	Status
Iodinated I-131 Albumin injection, solution	rx	2	2	SUPPLYING
Sodium Iothalamate I-125 Injection injection, solution	rx	1	1	SUPPLYING

Sole US supplier

Drugs where this labeler is currently the only active US supplier — a single point of failure if it exits.

At a glance

TypeLabeler
Labeler codes50914
Filing names1
Drugs (active)2
Drugs (all time)2
US registrations3
Packages3

Recent events

Shortages, recalls, and registration changes across all filing names.

Apr 15, 2019
RECALLRecall (Class II): Volumex (Iodinated I 131 Albumin) Injection USP, 25 uCi per 1 mL syringe, Rx Only, Manufactured for Daxor Corp., NY, NY…
Mar 11, 2019
RECALLRecall (Class II): Volumex (Iodinated I 131 Albumin) Injection USP, 25 uCi per 1 mL syringe, Rx Only, Manufactured for Daxor Corp., NY, NY…

Watch this company

Alerts for recalls, exits, and new registrations.

Facility locations, FDA inspections, and parent-company mapping are on the roadmap. Name variants reported to FDA under different spellings are merged into this profile; figures cover the entity across all its filing names.