FDA-Drug2016-04-13Class III

SODIUM IODIDE I 131 CAPSULE, USP DIAGNOSTIC ORAL , Rx only, Manufactured by Jubilant DraxImage, Inc., Kirkland, QC, Canada, NDC 65174-461-05

Jubilant Draximage Inc
Hazard

Labeling: Label Error on Declared Strength

Sold states
Nationwide
Affected count
90 vials (450 capsules)
Manufactured in
16751 Rte Trans-Canada, N/A, Kirkland, N/A, Canada
Products
SODIUM IODIDE I 131 CAPSULE, USP DIAGNOSTIC ORAL , Rx only, Manufactured by Jubilant DraxImage, Inc., Kirkland, QC, Canada, NDC 65174-461-05

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0812-2016

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