Drug recall D-095-2013
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.
Reason for recall
Presence of Particulate Matter; potential for charcoal particulates
Lots and codes
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.
Recall details
- Recalling firm
- Bracco Diagnostic Inc, Princeton, NJ
- Quantity
- 196,280 Vials
- Distribution
- Nationwide.
- Type
- Voluntary: Firm initiated
- Recall initiated
- August 14, 2012
- Terminated
- September 6, 2013
Related products
- Choletec – drug information
- NDC 0270-0083 Choletec · Mebrofenin 45 mg/1 · Bracco Diagnostics Inc