FDAFDA · Food and drugs·Recall number D-1189-2022
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.
Published July 20, 2022 · Recall initiated: June 16, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility: Out-of-specification test results obtained for Endotoxin testing.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- DRAXIMAGE MAA
- Manufacturer
- Jubilant Draximage Inc
- Distributor
- Product was distributed to retailers nationwide.
- Lot
- Lot # 1H005, exp. date Nov 30, 2023
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- Canada
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