# FDA recall D-1342-2019

> **Chiesi USA, Inc.** · Class II · drug recall initiated 2019-05-31.

## Product

Zileuton Extended-Release Tablets, 600 mg, 120-count bottles, Rx only, Distributed by: Prasco Laboratories, Mason, OH 45040 USA; NDC 66993-485-32.

## Reason for recall

Failed Dissolution Specifications: Out of specification result for dissolution.

## Distribution

Nationwide in the USA.

## Key facts

- **Recall number:** D-1342-2019
- **Recalling firm:** Chiesi USA, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-05-31
- **Report date:** 2019-06-19
- **Termination date:** 2021-03-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Cary, NC, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1342-2019

## Citation

> AI Analytics. FDA recall D-1342-2019. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/D-1342-2019. Source: US FDA. Licensed CC0.

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