Medications & Supplements/Prescription Drugs

Iso-Tex Diagnostics, Inc: Volumex Iodinated I 131 Albumin Injection Recalled for Lack of Sterility

Agency Publication Date: April 18, 2019

Summary

Iso-Tex Diagnostics, Inc. has recalled 54 syringes of Volumex (Iodinated I 131 Albumin) Injection USP (25 uCi per 1 mL), a prescription medication used for blood volume testing. The recall was initiated because environmental monitoring reports exceeded acceptable limits, meaning the sterility of the medication cannot be guaranteed. Consumers who received this injection should contact their healthcare provider immediately as a lack of sterility in an injectable drug can lead to serious infections.

Risk

The injection may not be sterile due to environmental monitoring failures at the manufacturing facility. Injecting a non-sterile product directly into the bloodstream can cause life-threatening infections or sepsis.

What You Should Do

Identify if you have received the affected medication by checking for Volumex (Iodinated I 131 Albumin) Injection USP, 25 uCi per 1 mL syringe, with NDC 50914-7720-8.
Specifically check the packaging for Lot Number V191004-927 with an expiration date of 05/10/19 (May 10, 2019).
Contact your healthcare provider or pharmacist immediately if you have received this medication or have concerns about a recent injection.
Return any remaining unused syringes of the affected lot to the place of purchase for a refund.
Contact Iso-Tex Diagnostics, Inc. directly for further instructions regarding the return process.
For additional questions or to report a problem, 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 provider 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-1136-2019

Lot Numbers:

V191004-927 (Exp. 05/10/19)

Date Ranges: 05/10/19

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 82652

Status: Resolved

Manufacturer: Iso-Tex Diagnostics, Inc

Sold By: Daxor Corp.

Manufactured In: United States

Units Affected: 54 1ml 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 received the affected medication by checking for Volumex (Iodinated I 131 Albumin) Injection USP, 25 uCi per 1 mL syringe, with NDC 50914-7720-8.

Specifically check the packaging for Lot Number V191004-927 with an expiration date of 05/10/19 (May 10, 2019).

Contact your healthcare provider or pharmacist immediately if you have received this medication or have concerns about a recent injection.

Return any remaining unused syringes of the affected lot to the place of purchase for a refund.

Contact Iso-Tex Diagnostics, Inc. directly for further instructions regarding the return process.

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