D-095-2013 Class III Terminated
FDA drug recall D-095-2013 was initiated by Bracco Diagnostic Inc on August 14, 2012 and is designated Class III. Reason for recall: Presence of Particulate Matter; potential for charcoal particulates The recall status is terminated (terminated September 6, 2013). Affected quantity: 196,280 Vials.
Recall Details
- Product Type
- Drugs
- Report Date
- December 26, 2012
- Initiation Date
- August 14, 2012
- Termination Date
- September 6, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 196,280 Vials
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.
Reason for Recall
Presence of Particulate Matter; potential for charcoal particulates
Distribution Pattern
Nationwide.
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.