# FDA recall D-095-2013

> **Bracco Diagnostic Inc** · Class III · drug recall initiated 2012-08-14.

## 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.

## Reason for recall

Presence of Particulate Matter; potential for charcoal particulates

## Distribution

Nationwide.

## Key facts

- **Recall number:** D-095-2013
- **Recalling firm:** Bracco Diagnostic Inc
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2012-08-14
- **Report date:** 2012-12-26
- **Termination date:** 2013-09-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Princeton, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-095-2013

## Citation

> AI Analytics. FDA recall D-095-2013. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/D-095-2013. Source: US FDA. Licensed CC0.

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