Draximage MAA 2 recalled over sterility concerns

Recall date

June 16, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

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 car…

Recall number

D-1189-2022

FDA classification

Class II

Brand / firm

Jubilant Draximage Inc

Sold / distributed

Product was distributed to retailers nationwide.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.