FDAFDA · Food and drugs·Recall number D-095-2013
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.
Published December 26, 2012 · Recall initiated: August 14, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Presence of Particulate Matter; potential for charcoal particulates
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- CHOLETEC
- Manufacturer
- Bracco Diagnostic Inc
- Distributor
- Nationwide.
- Lot
- 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.
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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