Sodium Iodide I 131 Diagnostic Capsule
FDA Recall NDC 65174-461
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Sodium Iodide I 131 Diagnostic (NDC 65174-461). A significant event, classified as Class III, was initiated on Mar 11, 2016 by Jubilant Draximage Inc., Dba Jubilant Radiopharma. The reported reason for this action was: "Labeling: Label Error on Declared Strength"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class III Terminated
Labeling: Label Error on Declared Strength
Mar 11, 2016
Apr 13, 2016
90 vials (450 capsules)
Recall Profile & Regulatory Data
Event ID
73586
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Jubilant Draximage Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Aug 07, 2017
Product Description
SODIUM IODIDE I 131 CAPSULE, USP DIAGNOSTIC ORAL , Rx only, Manufactured by Jubilant DraxImage, Inc., Kirkland, QC, Canada, NDC 65174-461-05
Batch or Lot Expiration Information
Lot# Lot Number 1670123; Exp 04/16
Affected Packages Involved in this Recall
65174-461-05Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
