RecallDepth
Class III Terminated

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.

Company
Bracco Diagnostic Inc
Recall Initiated
August 14, 2012
Posted
December 26, 2012
Recall Number
D-095-2013
Voluntary / Mandated
Voluntary: Firm initiated
Quantity
196,280 Vials
Firm Location
Princeton, NJ, United States

Reason for Recall

Presence of Particulate Matter; potential for charcoal particulates

Distribution

Nationwide.

Lot / Code Info

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.

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