FDA-Drug2019-03-27Class II
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.
Iso-Tex Diagnostics, Inc
Hazard
Lack of Assurance of Sterility: preliminary environmental monitoring report exceeds limits, therefore sterility cannot be assured.
Sold states
TN
Affected count
54 syringes
Manufactured in
1511 County Road 129, N/A, Alvin, TX, United States
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1008-2019Don't want to check this manually?
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