Reported Dec 26, 2012 · Terminated
Choletec - Kit for the Preparation of Technetium Tc 99m Mebrofenin, 10 vials per box, Nonradioactive, Diagnostic Use,…
Bracco Diagnostic Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Bracco Diagnostic Inc · 107 College Rd E · Princeton, NJ · 08540-6623
Is this the product you have?
- 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.
- Lot codes and dates
Lot #s: C0672Exp 09/30/2012C0689Exp 10/31/2012C0723Exp 12/31/2012C0799Exp 02/28/2013C0852Exp 05/31/2013
- Amount recalled
- 196,280 Vials
Where it was sold
- Nationwide
Why it was recalled
Presence of Particulate Matter; potential for charcoal particulates
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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