Drug 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.
D-1189-2022
Product summary
- Event
- Event 90455
- Status
- Terminated
- Classification
- Class II
- Quantity
- 519 cartons/30 vials each
- Official record key
drug-enforcement:D-1189-2022
Official wording
Reason: Lack of Assurance of Sterility: Out-of-specification test results obtained for Endotoxin testing.
Code information: Lot # 1H005, exp. date Nov 30, 2023
Distribution pattern: Product was distributed to retailers nationwide.
Derived failure modes
-
Potency or specification failure
Out-of-specification
-
Sterility assurance
Lack of Assurance of Sterility