Why it was recalled
Labeling: Label Error on Declared Strength
Product description
SODIUM IODIDE I 131 CAPSULE, USP DIAGNOSTIC ORAL , Rx only, Manufactured by Jubilant DraxImage, Inc., Kirkland, QC, Canada, NDC 65174-461-05
Lot numbers, UPCs & expiration codes
Lot Number 1670123; Exp 04/16
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0812-2016
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Mar 11, 2016
- FDA report date
- Apr 13, 2016
- Quantity
- 90 vials (450 capsules)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Jubilant Draximage Inc
Original FDA data
Every field from FDA enforcement report D-0812-2016, exactly as published.
Show all FDA fields
- City
- Kirkland
- Status
- Terminated
- Country
- Canada
- Event ID
- 73586
- Address
- 16751 Rte Trans-Canada
- Code information
- Lot Number 1670123; Exp 04/16
- Report date
- Apr 13, 2016
- Product type
- Drugs
- Recall number
- D-0812-2016
- Classification
- Class III
- Recalling firm
- Jubilant Draximage Inc
- Product quantity
- 90 vials (450 capsules)
- Termination date
- Aug 7, 2017
- Reason for recall
- Labeling: Label Error on Declared Strength
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- SODIUM IODIDE I 131 CAPSULE, USP DIAGNOSTIC ORAL , Rx only, Manufactured by Jubilant DraxImage, Inc., Kirkland, QC, Canada, NDC 65174-461-05
- Distribution pattern
- Nationwide
- Recall initiation date
- Mar 11, 2016
- Initial firm notification
- Center classification date
- Apr 6, 2016