# FDA recall D-1684-2012

> **Bracco Diagnostics Inc** · Class II · drug recall initiated 2012-06-01.

## Product

CARDIOGEN-82 (Rubidium Rb 82 Generator), 140 millicurie, Rx Only, For Elution of sterile nonpyrogenic Rubidium Chloride Rb 82, Manufactured for: Bracco Diagnostics Inc. Princeton, NJ 08543 by Medi-Physics, Inc. South Plainfield, NJ 07080, NDC 0270-0091-01

## Reason for recall

GMP deviation; Sr-82 levels exceeded alert limit specification

## Distribution

Nationwide and United Kingdom

## Key facts

- **Recall number:** D-1684-2012
- **Recalling firm:** Bracco Diagnostics Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2012-06-01
- **Report date:** 2012-10-03
- **Termination date:** 2013-03-18

- **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-1684-2012

## Citation

> AI Analytics. FDA recall D-1684-2012. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-1684-2012. Source: US FDA. Licensed CC0.

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