Status
Terminated
Drug Enforcement D-095-2013
Presence of Particulate Matter; potential for charcoal particulates
Classification
Class III
Report Date
December 26, 2012
Termination Date
September 6, 2013
Product Information
- Product description
- 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.
- Product quantity
- 196,280 Vials
- Reason for recall
- Presence of Particulate Matter; potential for charcoal particulates
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide.
Location & Firm
- Recalling firm
- Bracco Diagnostic Inc
- Address
-
107 College Rd E
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-095-2013
- Event ID
- 63535
- Recall initiation date
- August 14, 2012
- Center classification date
- December 19, 2012
- 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.
- More code info
- —