# FDA recall D-1536-2014

> **Bracco Diagnostic Inc** · Class III · drug recall initiated 2014-07-02.

## Product

E-Z-HD (barium sulfate) For Suspension (98% w/w), 340 g bottle, Rx Only, Manufactured by E-Z-EM Canada Inc., a subsidiary of E-Z-EM, Inc., Lake Success, NY 11042, NDC 32909-764-01.

## Reason for recall

Subpotent Drug: Low out of specification results for both pH and assay obtained during routine stability testing after 36 months.

## Distribution

Nationwide and Puerto Rico

## Key facts

- **Recall number:** D-1536-2014
- **Recalling firm:** Bracco Diagnostic Inc
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2014-07-02
- **Report date:** 2014-08-20
- **Termination date:** 2015-06-30

- **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-1536-2014

## Citation

> AI Analytics. FDA recall D-1536-2014. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/D-1536-2014. Source: US FDA. Licensed CC0.

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