Iso-Tex Diagnostics, Inc recalls Volumex (Iodinated I 131 Albumin) Injection USP, 25 uCi per 1 mL syringe, Rx Only, Manufactured for Daxor Corp., NY, NY;
Recalled March 27, 2019 · FDA recall D-1008-2019 · Iso-Tex Diagnostics
Hazard
Lack of Assurance of Sterility: preliminary environmental monitoring report exceeds limits, therefore sterility cannot be assured. · FDA Class II
Units
54 syringes
Sold at
TN
Description
Lack of Assurance of Sterility: preliminary environmental monitoring report exceeds limits, therefore sterility cannot be assured.
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.
Manufacturer(s)
Iso-Tex Diagnostics, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →