FDAMarch 11, 2019drug
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.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Lack of Assurance of Sterility: preliminary environmental monitoring report exceeds limits, therefore sterility cannot be assured.
What to do
FDA enforcement status: Terminated
Brands named
iso tex diagnosticsisoiso tex
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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