FDAClass IIIDecember 26, 2012

Choletec - Kit for the Preparation of Technetium Tc 99m recall: Particulate Matter

Choletec - Kit for the Preparation of Technetium Tc 99m Mebrofenin, 10 vials per box, Nonradioactive, Diagnostic Use, For Intravenous Use, Multidose…

Why was Choletec - Kit for the Preparation of Technetium Tc 99m recalled?

Presence of Particulate Matter; potential for charcoal particulates

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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.

Product
Choletec - Kit for the Preparation of Technetium Tc 99m Mebrofenin, 10 vials per box, Nonradioactive, Diagnostic Use, For Intravenous Use, Multidose…
Recalling firm
Bracco Diagnostic Inc
Quantity
196,280 Vials
Distribution
Nationwide.
Recall date
December 26, 2012
Classification
Class III
Status
Terminated
Agency
FDA (drug)
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