FDA recall D-1189-2022

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 for recall

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

Distribution

Product was distributed to retailers nationwide.

Key facts

Status

Terminated

Initiation date

2022-06-16

Report date

2022-07-20

Termination date

2023-07-25

Voluntary/Mandated

Voluntary: Firm initiated

Location

Kirkland, Canada

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1189-2022