SODIUM IODIDE I 131 CAPSULE, USP DIAGNOSTIC ORAL , Rx only, Manufactured by Jubilant DraxImage, Inc., Kirkland, QC, Canada, NDC 65174-461-05
FDA recall notice · announced April 13, 2016 · Jubilant Draximage
Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.
The 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
Notes
Distribution: Nationwide
Lot/code information: Lot Number 1670123; Exp 04/16
Quantity: 90 vials (450 capsules)
Status: Terminated
Products in this recall event:
- SODIUM IODIDE I 131 CAPSULE, USP DIAGNOSTIC ORAL , Rx only, Manufactured by Jubilant DraxImage, Inc., Kirkland, QC, Canada, NDC 65174-461-05 (D-0812-2016)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.