# FDA recall D-0609-2018

> **Bracco Diagnostics Inc.** · Class II · drug recall initiated 2018-03-08.

## Product

E-Z-Paste Barium Sulfate Esophageal Cream (60% w/w),  454 g tube, Rx only, Manufactured by E-Z-EM Canada Inc. for E-Z-EM Inc. a subsidiary of Bracco Diagnostics Inc., Monroe Twp., NJ 0883, NDC 32909-770-01

## Reason for recall

Failed stability specifications: Out-of-specification (OOS) result for a preservative assay - methylparaben - during stability testing of one lot.

## Distribution

Product was distributed throughout the United States, Hong Kong and New Zealand.

## Key facts

- **Recall number:** D-0609-2018
- **Recalling firm:** Bracco Diagnostics Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-03-08
- **Report date:** 2018-04-04
- **Termination date:** 2019-03-01

- **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-0609-2018

## Citation

> AI Analytics. FDA recall D-0609-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/D-0609-2018. Source: US FDA. Licensed CC0.

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