FDA recall D-0812-2016
Jubilant Draximage Inc · Class III · drug
Product
SODIUM IODIDE I 131 CAPSULE, USP DIAGNOSTIC ORAL , Rx only, Manufactured by Jubilant DraxImage, Inc., Kirkland, QC, Canada, NDC 65174-461-05
Reason for recall
Labeling: Label Error on Declared Strength
Distribution
Nationwide
Key facts
- Status
- Terminated
- Initiation date
- 2016-03-11
- Report date
- 2016-04-13
- Termination date
- 2017-08-07
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Kirkland, N/A, Canada
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0812-2016