# FDA recall D-1083-2014

> **Bracco Diagnostics Inc** · Class III · drug recall initiated 2013-12-16.

## Product

VoLumen Barium Sulfate Suspension (0.1 % w/v, 0.1 ww/w), 450 mL bottle, Rx Only.  Manufactured by E-Z-EM Canada Inc. a subsidiary or E-Z-EM, Inc. Lake Success, NY 11042.  NDC 32909-945-03.

## Reason for recall

Failed Stability Testing: This product is below specification for preservative content.

## Distribution

Nationwide including Puerto Rico

## Key facts

- **Recall number:** D-1083-2014
- **Recalling firm:** Bracco Diagnostics Inc
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-12-16
- **Report date:** 2014-02-19
- **Termination date:** 2015-01-23

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1083-2014

## Citation

> AI Analytics. FDA recall D-1083-2014. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/D-1083-2014. Source: US FDA. Licensed CC0.

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