D-0812-2016 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- April 13, 2016
- Initiation Date
- March 11, 2016
- Termination Date
- August 7, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 90 vials (450 capsules)
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
Distribution Pattern
Nationwide
Code Information
Lot Number 1670123; Exp 04/16