Medications & Supplements/Prescription Drugs

Iso-Tex Diagnostics, Inc: Volumex (Iodinated I 131 Albumin) Injection Recalled for Sterility Concerns

Agency Publication Date: March 18, 2019

Summary

Iso-Tex Diagnostics, Inc. has recalled 54 syringes of Volumex (Iodinated I 131 Albumin) Injection USP (25 uCi per 1 mL syringe). The recall was initiated because environmental monitoring reports at the manufacturing facility exceeded safety limits, meaning the sterility of the injectable medication cannot be guaranteed. This medication is typically used for blood volume and cardiac output studies and was distributed to Tennessee. If you have been administered this product, you should contact your healthcare provider immediately.

Risk

If an injectable drug is not sterile, it may contain bacteria or other microorganisms that could cause serious infections or sepsis when introduced into the bloodstream.

What You Should Do

Identify if you have the affected product by checking the label for Volumex (Iodinated I 131 Albumin) Injection USP, 25 uCi per 1 mL syringe with NDC 50914-7720-8.
Check the packaging for Lot Number V190603-922 with an expiration date of 04/05/19.
Contact your healthcare provider or pharmacist immediately for guidance if you believe you have received this injection or if you have any of the affected syringes in your possession.
Return any unused syringes from Lot V190603-922 to the pharmacy or place of purchase for a refund.
Contact Iso-Tex Diagnostics, Inc. at their facility in Alvin, Texas, for further instructions regarding the return of these 54 syringes.
For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Healthcare consultation and refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Volumex (Iodinated I 131 Albumin) Injection USP, 25 uCi per 1 mL syringe

Model:

NDC 50914-7720-8

Recall #: D-1008-2019

Lot Numbers:

V190603-922 (Exp. 04/05/19)

Date Ranges: 04/05/19

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 82397

Status: Resolved

Manufacturer: Iso-Tex Diagnostics, Inc

Sold By: Daxor Corp.

Manufactured In: United States

Units Affected: 54 syringes

Distributed To: Tennessee

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Identify if you have the affected product by checking the label for Volumex (Iodinated I 131 Albumin) Injection USP, 25 uCi per 1 mL syringe with NDC 50914-7720-8.

Check the packaging for Lot Number V190603-922 with an expiration date of 04/05/19.

Contact your healthcare provider or pharmacist immediately for guidance if you believe you have received this injection or if you have any of the affected syringes in your possession.

Return any unused syringes from Lot V190603-922 to the pharmacy or place of purchase for a refund.

Contact Iso-Tex Diagnostics, Inc. at their facility in Alvin, Texas, for further instructions regarding the return of these 54 syringes.

For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.