August 2012 FDA Recall Choletec by Bracco Diagnostic Inc
D-095-2013 - Presence of Particulate Matter; potential for charcoal particulates

This Class III drug recall was voluntarily initiated by Bracco Diagnostic Inc on August 14, 2012 for the product Choletec. The FDA reported the reason for recall as presence of particulate matter; potential for charcoal particulates. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-095-2013

Reason for Recall
Presence of Particulate Matter; potential for charcoal particulates
Initiated
08-14-2012
Reported
12-26-2012
Quantity
196,280 Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
63535
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.
09-06-2013
Product Description About Product Description
Full technical description of the product.
Choletec - Kit for the Preparation of Technetium Tc 99m Mebrofenin, 10 vials per box, Nonradioactive, Diagnostic Use, For Intravenous Use, Multidose, Rx Only, Manufactured for Bracco Diagnostics Inc. Princeton, NJ 08543, by Hollister-Stier Laboratories LLC, Spokane Washington 99207, NDC 0270-0083-20.

Batch or Lot Expiration Information

Lot# s: C0672, Exp 09/30/2012; C0689, Exp 10/31/2012; C0723, Exp 12/31/2012; C0799, Exp 02/28/2013; C0852, Exp 05/31/2013.

Affected Packages Involved in this Recall

0270-0083-20 Choletec