FDA-Drug2022-07-20Class II
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.
Jubilant Draximage Inc
Hazard
Lack of Assurance of Sterility: Out-of-specification test results obtained for Endotoxin testing.
Sold states
Product was distributed to retailers nationwide.
Affected count
519 cartons/30 vials each
Manufactured in
16751 Rte Transcanadienne, Kirkland, Canada
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1189-2022Don't want to check this manually?
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