D-0812-2016 Class III Terminated
FDA drug recall D-0812-2016 was initiated by Jubilant Draximage Inc on March 11, 2016 and is designated Class III. Reason for recall: Labeling: Label Error on Declared Strength The recall status is terminated (terminated August 7, 2017). Affected quantity: 90 vials (450 capsules).
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