Volumex (Iodinated I 131 Albumin) Injection USP, 25 uCi per 1 mL syringe recall — FDA D-1136-2019
Lack of Assurance of Sterility: environmental monitoring report exceeds limits, therefore sterility cannot be assured.
Overview of recall records associated with Iso-Tex Diagnostics, Inc., including dates, categories and classifications where available.
Classification mix: Class II: 1.
Lack of Assurance of Sterility: environmental monitoring report exceeds limits, therefore sterility cannot be assured.
This page summarizes recall records in which the official source identifies Iso-Tex Diagnostics, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.