March 2016 FDA Recall Sodium Iodide I 131 Diagnostic by Jubilant Draximage Inc
D-0812-2016 - Labeling

This Class III drug recall was voluntarily initiated by Jubilant Draximage Inc on March 11, 2016 for the product Sodium Iodide I 131 Diagnostic. The FDA reported the reason for recall as labeling. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0812-2016

Reason for Recall
Labeling: Label Error on Declared Strength
Initiated
03-11-2016
Reported
04-13-2016
Quantity
90 vials (450 capsules)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73586
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Jubilant Draximage Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-07-2017
Product Description About Product Description
Full technical description of the product.
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

65174-461-05 Sodium Iodide I 131 Diagnostic