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Iso-Tex Diagnostics, Inc

No ongoing recalls currently shown

Based on the official records currently available to Public Health Trace, no recalls naming Iso-Tex Diagnostics, Inc are currently shown as ongoing. The 2 records below are historical recall records.

Public Health Trace has 2 recalls naming Iso-Tex Diagnostics, Inc as the recalling firm, republished from official FDA and USDA sources.

Recall history - 2 terminated records

Recalls by year

A bar chart of the number of recalls naming this company by year.

Recalls by year
YearRecalls
20192
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FDA Recall TerminatedTerminated: December 15, 2020Historical recordClass 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.

by Iso-Tex Diagnostics, Inc

Reason
Lack of Assurance of Sterility: environmental monitoring report exceeds limits, therefore sterility cannot be assured.
Published
April 24, 2019
Distribution
TN

View recall →

FDA Recall TerminatedTerminated: December 15, 2020Historical recordClass 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.

by Iso-Tex Diagnostics, Inc

Reason
Lack of Assurance of Sterility: preliminary environmental monitoring report exceeds limits, therefore sterility cannot be assured.
Published
March 27, 2019
Distribution
TN

View recall →

Showing 1–2 of 2 results

Some FDA recall records on this page come from FDA's Enforcement Report database. Not every Enforcement Report record has a separate FDA.gov recall-announcement page.

This page lists recalls that name Iso-Tex Diagnostics, Inc as the recalling firm in the official source notice. It is not a safety rating, ranking, or statement that the company acted negligently. Read the full medical disclaimer.

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