December 2013 FDA Recall Drug by Bracco Diagnostics Inc
D-1083-2014 - Failed Stability Testing

This Class III drug recall was voluntarily initiated by Bracco Diagnostics Inc on December 16, 2013 for the product Drug. The FDA reported the reason for recall as failed stability testing. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1083-2014

Reason for Recall
Failed Stability Testing: This product is below specification for preservative content.
Initiated
12-16-2013
Reported
02-19-2014
Quantity
54,648 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
67262
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 Diagnostics 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 including Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-23-2015
Product Description About Product Description
Full technical description of the product.
VoLumen Barium Sulfate Suspension (0.1 % w/v, 0.1 ww/w), 450 mL bottle, Rx Only. Manufactured by E-Z-EM Canada Inc. a subsidiary or E-Z-EM, Inc. Lake Success, NY 11042. NDC 32909-945-03.

Batch or Lot Expiration Information

Lot# : 67603, Expiry: 2/2014