Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Volumex (Iodinated I 131 Albumin) Injection USP Recalled by Iso-Tex Diagnostics, Inc Due to Lack of Assurance of Sterility: preliminary environmental monitoring...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Iso-Tex Diagnostics, Inc directly.
Affected Products
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.
Quantity: 54 syringes
Why Was This Recalled?
Lack of Assurance of Sterility: preliminary environmental monitoring report exceeds limits, therefore sterility cannot be assured.
Where Was This Sold?
This product was distributed to 1 state: TN
About Iso-Tex Diagnostics, Inc
Iso-Tex Diagnostics, Inc has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report