Recalls / Class II
Class IID-1189-2022
Product
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.
- Brand name
- Draximage Maa
- Generic name
- Kit For The Preparation Of Technetium Tc 99m Albumin Aggregated
- Active ingredient
- Albumin Aggregated
- Route
- Intravenous
- NDC
- 65174-270
- FDA application
- BLA017881
- Affected lot / code info
- Lot # 1H005, exp. date Nov 30, 2023
Why it was recalled
Lack of Assurance of Sterility: Out-of-specification test results obtained for Endotoxin testing.
Recalling firm
- Firm
- Jubilant Draximage Inc
- Manufacturer
- Jubilant DraxImage Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 16751 Rte Transcanadienne, Kirkland, N/A, Canada
Distribution
- Quantity
- 519 cartons/30 vials each
- Distribution pattern
- Product was distributed to retailers nationwide.
Timeline
- Recall initiated
- 2022-06-16
- FDA classified
- 2022-07-08
- Posted by FDA
- 2022-07-20
- Terminated
- 2023-07-25
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1189-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.