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.

Recall Number: D-1136-2019

Firm: Iso-Tex Diagnostics, Inc

Classification: Class II

Status: Terminated

Report Date: 20190424

Initiation Date: 20190415

Termination Date: 20201215

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.