Class III · Low risk
Fyarro (albumin-bound)
Failed Stability Specifications
Volumex (Iodinated I 131 Albumin) (Iodinated I-131 Albumin)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility: preliminary environmental monitoring report exceeds limits, therefore sterility cannot be assured.
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
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.
Affected NDC
50914-7720-08
Compare with the code on your package — it is the most precise check available.
Drug: Albumin
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Volumex Iodinated I-131 Albumin NDC 50914-7720 |
HUMAN SERUM ALBUMIN I-131 .025 mCi/mL | Injection, Solution Intravenous |
Iso-Tex Diagnostics, Inc. | Rx |
- Recalling firm
- Iso-Tex Diagnostics, Inc
- NDC code
- 50914-7720-8
- Origin
- TX, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1008-2019 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Albumin recalls
See all
Class II · Moderate risk
Draximage MAA
Lack of Assurance of Sterility: Out-of-specification test results obtained for Endotoxin testing.
Class II · Moderate risk
C-*Albumin Eye Drop 10% S
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Class II · Moderate risk
C-Albumin 5% Ophth Solution
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
Class II · Moderate risk
PACLITAXEL ALBUMIN 185 mg /100 ml NS IVPB
Lack of Assurance of Sterility
Other recalls by Iso-Tex Diagnostics, Inc
All 2019 recalls
Class II · Moderate risk
Volumex (Iodinated I 131 Albumin)
Lack of Assurance of Sterility: environmental monitoring report exceeds limits, therefore sterility cannot be assured.
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