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Iso-Tex Diagnostics Recalls
2 recalls on record · March 27, 2019 to April 24, 2019 · Drugs
April 24, 2019DrugsFDA
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;
Hazard: Lack of Assurance of Sterility: environmental monitoring report exceeds limits, therefore sterility cannot be assured.
March 27, 2019DrugsFDA
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;
Hazard: Lack of Assurance of Sterility: preliminary environmental monitoring report exceeds limits, therefore sterility cannot be assured.