Drug product
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
Product summary
- Event
- Event 73586
- Status
- Terminated
- Classification
- Class III
- Quantity
- 90 vials (450 capsules)
- Official record key
drug-enforcement:D-0812-2016
Official wording
Reason: Labeling: Label Error on Declared Strength
Code information: Lot Number 1670123; Exp 04/16
Distribution pattern: Nationwide
Derived failure modes
-
Labeling or packaging
Labeling: Label Error