CLASS II Drug recall · Reported 27 Mar 2019 · FDA Enforcement Report
Volumex (Iodinated I 131 Albumin) Injection USP, 25 uCi per syringe recalled
Iso-Tex Diagnostics is recalling Volumex (Iodinated I 131 Albumin) Injection USP, 25 uCi per syringe, distributed in Tennessee. The recall was initiated on 11 Mar 2019 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1008-2019
- FDA event ID
- 82397
- Recalling firm
- Iso-Tex Diagnostics, Alvin, TX
- Brand
- Volumex
- Manufacturer
- Iso-Tex Diagnostics, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 Mar 2019
- FDA classified
- 18 Mar 2019
- Reported
- 27 Mar 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 11 Mar 2019 | Recall initiated by company | |
| 18 Mar 2019 | Classified by FDA | +7 days |
| 27 Mar 2019 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility: preliminary environmental monitoring report exceeds limits, therefore sterility cannot be assured.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
TN
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility: preliminary environmental monitoring report exceeds limits, therefore sterility cannot be assured.
Which lots are affected?
Lot: V190603-922, Exp. 04/05/19
Where was it sold?
TN
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Iso-Tex Diagnostics
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Volumex (Iodinated I 131 Albumin) Injection USP, 25 uCi per syringe recalledVolumex | Iso-Tex Diagnostics | Sterility | TN |
Other Iodinated I-131 Albumin recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Volumex (Iodinated I 131 Albumin) Injection USP, 25 uCi per syringe recalledVolumex | Iso-Tex Diagnostics | Sterility | TN |