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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