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.

Recall Number: D-1189-2022

Firm: Jubilant Draximage Inc

Classification: Class II

Status: Terminated

Report Date: 20220720

Initiation Date: 20220616

Termination Date: 20230725

Lack of Assurance of Sterility: Out-of-specification test results obtained for Endotoxin testing.

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.