Choletec Kit (Bracco) – Particulate Matter Risk (2012)
Class III: A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences
Class III recall indicates unlikely adverse health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Bracco Diagnostic Inc
Lot Codes / Batch Numbers
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.
Products Sold
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.
Bracco Diagnostic Inc is recalling Choletec - Kit for the Preparation of Technetium Tc 99m Mebrofenin, 10 vials per box, Nonradioactive due to Presence of Particulate Matter; potential for charcoal particulates. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Presence of Particulate Matter; potential for charcoal particulates
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026