Iso-Tex Diagnostics recalls
FDA enforcement reports naming Iso-Tex Diagnostics, Inc as the recalling firm.
- Recall reports
- 2
- Class I (serious)
- 0
- Most recent report
- Apr 24, 2019
- Apr 24, 2019Volumex (Iodinated I 131 Albumin) Injection USP, 25 uCi per 1 mL syringe, Rx Only, Manu…Drug · Iso-Tex Diagnostics, IncLack of Assurance of Sterility: environmental monitoring report exceeds limits, therefore sterility cannot be assured.Class II
- Mar 27, 2019Volumex (Iodinated I 131 Albumin) Injection USP, 25 uCi per 1 mL syringe, Rx Only, Manu…Drug · Iso-Tex Diagnostics, IncLack of Assurance of Sterility: preliminary environmental monitoring report exceeds limits, therefore sterility cannot be assured.Class II