FDA 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

Distribution

Nationwide.

Key facts

Status

Terminated

Initiation date

2012-08-14

Report date

2012-12-26

Termination date

2013-09-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-095-2013