May 2015 FDA Recall Drug by Bracco Diagnostic Inc
D-1147-2015 - Failed stability specifications

This Class III drug recall was voluntarily initiated by Bracco Diagnostic Inc on May 27, 2015 for the product Drug. The FDA reported the reason for recall as failed stability specifications. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1147-2015

Reason for Recall
Failed stability specifications:This recall has been initiated due to out of specification results for viscosity.
Initiated
05-27-2015
Reported
07-01-2015
Quantity
1008 boxes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71442
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.
Bracco Diagnostic 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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-19-2016
Product Description About Product Description
Full technical description of the product.
E-Z-CAT Dry Barium Sulfate for Suspension (2% w/w after mixing), 23 g foil pouches, Rx only, Manufactured by E-Z-EM Canada Inc. a subsidiary of E-Z-EM Inc., Lake Success NY NDC 32909-727-01

Batch or Lot Expiration Information

Lot# : 00513716, 00514712, Exp 03/2016