CLASS II Drug recall · Reported 20 Jul 2022 · FDA Enforcement Report
Draximage MAA (Kit for the preparation of Technnetium Tc recalled
Jubilant Draximage is recalling Draximage MAA (Kit for the preparation of Technnetium Tc 99m Albumin Aggregate) 2.5 mg, distributed nationwide in the US. The recall was initiated on 16 Jun 2022 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-1189-2022
- FDA event ID
- 90455
- Recalling firm
- Jubilant Draximage, Kirkland
- Brand
- Draximage Maa
- Manufacturer
- Jubilant DraxImage Inc
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Jun 2022
- FDA classified
- 8 Jul 2022
- Reported
- 20 Jul 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 16 Jun 2022 | Recall initiated by company | |
| 8 Jul 2022 | Classified by FDA | +22 days |
| 20 Jul 2022 | Published in enforcement report | +12 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: Out-of-specification test results obtained for Endotoxin testing.
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
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.
Where it was distributed
Product was distributed to retailers nationwide.
Stores named: Costco
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility: Out-of-specification test results obtained for Endotoxin testing.
Which lots are affected?
Lot # 1H005, exp. date Nov 30, 2023
Where was it sold?
Product was distributed to retailers nationwide.
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 Jubilant Draximage
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Draximage Dtpa (Kit For The Preparation OF Technetium TC recalled | Jubilant Draximage | Potency & Assay | Nationwide |
| Drug | CLASS III | Sodium Iodide I, USP Diagnostic Oral recalled by Jubilant DraximageSodium Iodide I 131 Diagnostic | Jubilant Draximage | Other | Nationwide |