Volumex Injection USP recalled over sterility concerns
- Recall date
- March 11, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- 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…
- Recall number
- D-1008-2019
- FDA classification
- Class II
- Brand / firm
- Iso-Tex Diagnostics, Inc
- Sold / distributed
- TN
Why it was recalled
Lack of Assurance of Sterility: preliminary environmental monitoring report exceeds limits, therefore sterility cannot be assured.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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.
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