Recalls / Class III
Class IIID-0812-2016
Product
SODIUM IODIDE I 131 CAPSULE, USP DIAGNOSTIC ORAL , Rx only, Manufactured by Jubilant DraxImage, Inc., Kirkland, QC, Canada, NDC 65174-461-05
- Brand name
- Sodium Iodide I 131 Diagnostic
- Generic name
- Sodium Iodide I 131
- Active ingredient
- Sodium Iodide I-131
- Route
- Oral
- NDC
- 65174-461
- FDA application
- NDA021305
- Affected lot / code info
- Lot Number 1670123; Exp 04/16
Why it was recalled
Labeling: Label Error on Declared Strength
Recalling firm
- Firm
- Jubilant Draximage Inc
- Manufacturer
- Jubilant DraxImage Inc., dba Jubilant Radiopharma
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 16751 Rte Trans-Canada, N/A, Kirkland, N/A N/A, Canada
Distribution
- Quantity
- 90 vials (450 capsules)
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2016-03-11
- FDA classified
- 2016-04-06
- Posted by FDA
- 2016-04-13
- Terminated
- 2017-08-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0812-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.