June 2013 FDA Recall Gastrografin by Bracco Diagnostics Inc
D-885-2013 - Presence of foreign substance

This Class II drug recall was voluntarily initiated by Bracco Diagnostics Inc on June 21, 2013 for the product Gastrografin. The FDA reported the reason for recall as presence of foreign substance. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-885-2013

Reason for Recall
Presence of foreign substance: One lot of the product may contain black foreign particles
Initiated
06-21-2013
Reported
08-21-2013
Quantity
29,436 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
65878
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
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
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.
Gastrografin (Diatrizoate Meglumine and Diatrizoate Sodium Solution), USP, 37% Organically Bound Iodine, 120 ml bottle, Rx only, Manufactured for Bracco Diagnostics Inc. Princeton, NJ 08543 by Therapex, Division of E-Z-EM Canada Inc. Anjou Quebec H1J2Z4, Canada, NDC 0270-0445-40

Batch or Lot Expiration Information

Lot# 00500512, Exp. 11/15

Affected Packages Involved in this Recall

0270-0445-35 Gastrografin
0270-0445-40 Gastrografin