Class III · Low risk
Fyarro (albumin-bound)
Failed Stability Specifications
Draximage MAA
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility: Out-of-specification test results obtained for Endotoxin testing.
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
Draximage MAA (Kit for the preparation of Technnetium Tc 99m Albumin Aggregate) 2.5 mg per vial, 30 glass vials per carton, Rx Only, Manufactured for Jubilant Draximage Inc. Kirkland, Canada, NDC 65174-270-30.
Affected NDC
65174-0270-30
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 |
|---|---|---|---|---|
| Draximage Maa Kit for the preparation of Technetium Tc 99m Albumin aggregated NDC 65174-0270 |
ALBUMIN AGGREGATED 2.5 mg/1 | Injection, Powder, for Solution Intravenous |
Jubilant DraxImage Inc | Rx |
- Recalling firm
- Jubilant Draximage Inc
- NDC code
- 65174-270-30
- Origin
- Canada
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1189-2022 · 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
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
Class II · Moderate risk
Volumex (Iodinated I 131 Albumin)
Lack of Assurance of Sterility: environmental monitoring report exceeds limits, therefore sterility cannot be assured.
Other recalls by Jubilant Draximage Inc
All 2022 recalls
Class II · Moderate risk
Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection
Failed Stability Specifications
Class II · Moderate risk
Draximage Dtpa
Failed Stability Specifications
Class III · Low risk
Sodium Iodide I 131 Capsule
Labeling: Label Error on Declared Strength
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