Class II Recall

Jubilant Draximage Inc

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
Lack of Assurance of Sterility: Out-of-specification test results obtained for Endotoxin testing.
Classification
Class II
Status
Terminated
Lot
Lot # 1H005, exp. date Nov 30, 2023
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.