Product: 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.
Reason for recall: Lack of Assurance of Sterility: environmental monitoring report exceeds limits, therefore sterility cannot be assured.
Recall initiated: 20190415
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated