Jubilant Draximage Inc recalls Draximage MAA (Kit for the preparation of Technnetium Tc 99m Albumin Aggregate) 2.5 mg per vial, 30 glass vials per cart
Recalled July 20, 2022 · FDA recall D-1189-2022 · Jubilant Draximage
Hazard
Lack of Assurance of Sterility: Out-of-specification test results obtained for Endotoxin testing. · FDA Class II
Units
519 cartons/30 vials each
Sold at
Product was distributed to retailers nationwide.
Description
Lack of Assurance of Sterility: Out-of-specification test results obtained for Endotoxin testing.
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.
Manufacturer(s)
Jubilant Draximage Inc
Made in
Canada
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →