Iso-Tex Diagnostics, Inc.
NDC labeler code: 50914
What is a labeler?
The company whose name is on the package and in the FDA’s National Drug Code (NDC) Directory. It may make the medicine itself or sell medicine made by another company. The first part of every NDC code identifies the labeler.
Official FDA data only
Products, approvals and recalls come from the FDA (NDC Directory, Drugs@FDA, enforcement reports). Recalls are linked to this company by the NDC labeler code on the recalled product.
Questions about your medicine: ask your doctor or pharmacist. In an emergency, call 911.
Prescription medicines
- Iodinated I-131 albuminMegatope, Volumex · 2 products
- Sodium iothalamate I-125 injectionGlofil-125 · 1 product
FDA applications for these products
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| February 23, 1976 | BLA017837 | Iodinated I-131 albumin MEGATOPE | Iso Tex |
| February 12, 1974 | NDA017279 | Sodium iothalamate I-125 injection GLOFIL-125 | Isotex |
The sponsor is the company that holds the FDA application; it can differ from the labeler.
Recall timeline
2019
-
April 15, 2019 · Class II · Terminated · D-1136-2019 · Iodinated I-131 albumin
Lack of Assurance of Sterility: environmental monitoring report exceeds limits, therefore sterility cannot be assured.
Volumex (Iodinated I 131 Albumin) Injection USP, 25 uCi per 1 mL syringe, Rx Only, Manufactured for Daxor Corp., NY, NY; By: Iso-Tex Diagnostics, Inc.; NDC 50914-7720-8.
-
March 11, 2019 · Class II · Terminated · D-1008-2019 · Iodinated I-131 albumin
Lack of Assurance of Sterility: preliminary environmental monitoring report exceeds limits, therefore sterility cannot be assured.
Volumex (Iodinated I 131 Albumin) Injection USP, 25 uCi per 1 mL syringe, Rx Only, Manufactured for Daxor Corp., NY, NY; By: Iso-Tex Diagnostics, Inc.; NDC 50914-7720-8.
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Next steps
- Find a pharmacy near youAsk which company made your medicine and whether it is recalled
- Latest FDA drug recallsAll companies, newest first
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Sources
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026