July 2014 FDA Recall E-z-hd by Bracco Diagnostic Inc
D-1536-2014 - Subpotent Drug

This Class III drug recall was voluntarily initiated by Bracco Diagnostic Inc on July 2, 2014 for the product E-z-hd. The FDA reported the reason for recall as subpotent drug. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1536-2014

Reason for Recall
Subpotent Drug: Low out of specification results for both pH and assay obtained during routine stability testing after 36 months.
Initiated
07-02-2014
Reported
08-20-2014
Quantity
216,792 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
68812
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 and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-30-2015
Product Description About Product Description
Full technical description of the product.
E-Z-HD (barium sulfate) For Suspension (98% w/w), 340 g bottle, Rx Only, Manufactured by E-Z-EM Canada Inc., a subsidiary of E-Z-EM, Inc., Lake Success, NY 11042, NDC 32909-764-01.

Batch or Lot Expiration Information

Lot# 's: 64205, 64206, 64200, 64201, 64202, 64203, 64204, 64207, 64264, Exp 05/15; 64265, 64267, 64268, 64270, 64271, Exp 06/15

Affected Packages Involved in this Recall

32909-764-01 E-z-hd