Drug 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.
D-095-2013
Product summary
- Event
- Event 63535
- Status
- Terminated
- Classification
- Class III
- Quantity
- 196,280 Vials
- Official record key
drug-enforcement:D-095-2013
Official wording
Reason: Presence of Particulate Matter; potential for charcoal particulates
Code 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.
Distribution pattern: Nationwide.
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter