Sodium Iodide I 131 Capsule recall: Labeling Error
SODIUM IODIDE I 131 CAPSULE, USP DIAGNOSTIC ORAL , Rx only, Manufactured by Jubilant DraxImage, Inc., Kirkland, QC, Canada, NDC 65174-461-05
Why was Sodium Iodide I 131 Capsule recalled?
Labeling: Label Error on Declared Strength
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Number 1670123; Exp 04/16
- Product
- SODIUM IODIDE I 131 CAPSULE, USP DIAGNOSTIC ORAL , Rx only, Manufactured by Jubilant DraxImage, Inc., Kirkland, QC, Canada, NDC 65174-461-05
- Recalling firm
- Jubilant Draximage Inc
- Quantity
- 90 vials (450 capsules)
- Distribution
- Nationwide
- Recall date
- April 13, 2016
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)