PlainRecalls
FDA Drug Low Class III Terminated

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

Reported: April 13, 2016 Initiated: March 11, 2016 #D-0812-2016

Product Description

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

Details

Recalling Firm
Jubilant Draximage Inc
Units Affected
90 vials (450 capsules)
Distribution
Nationwide
Location
Kirkland, N/A

Frequently Asked Questions

What product was recalled?
SODIUM IODIDE I 131 CAPSULE, USP DIAGNOSTIC ORAL , Rx only, Manufactured by Jubilant DraxImage, Inc., Kirkland, QC, Canada, NDC 65174-461-05. Recalled by Jubilant Draximage Inc. Units affected: 90 vials (450 capsules).
Why was this product recalled?
Labeling: Label Error on Declared Strength
Which agency issued this recall?
This recall was issued by the FDA Drug on April 13, 2016. Severity: Low. Recall number: D-0812-2016.