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.
Reason for recall: Lack of Assurance of Sterility: Out-of-specification test results obtained for Endotoxin testing.
Recall initiated: 20220616
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated