Class III โ€” Low Risk

Low risk โ€” use of or exposure to this product is not likely to cause adverse health consequences.

Choletec - Kit for the Preparation of Technetium Tc 99m Mebrofenin Recalled by Bracco Diagnostic Inc Due to Presence of Particulate Matter; potential for charcoal particulates

Date: August 14, 2012
Company: Bracco Diagnostic Inc
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Bracco Diagnostic Inc directly.

Affected Products

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.

Quantity: 196,280 Vials

Why Was This Recalled?

Presence of Particulate Matter; potential for charcoal particulates

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Bracco Diagnostic Inc

Bracco Diagnostic Inc has 6 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report