# FDA recall D-0367-2024

> **Stason Pharmaceuticals, Inc.** · Class III · drug recall initiated 2024-02-09.

## Product

Mercaptopurine Tablets, USP 50 mg, packaged in: a) 25-count bottle (NDC 69076-913-02), b) 250-count bottle (NDC 69076-913-25), Rx only, Manufactured for: Quinn Pharmaceuticals, Boca Raton, FL, www.quinnrx.com

## Reason for recall

Failed Dissolution Specifications: results slightly under spec at at 9-months.

## Distribution

USA Nationwide

## Key facts

- **Recall number:** D-0367-2024
- **Recalling firm:** Stason Pharmaceuticals, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2024-02-09
- **Report date:** 2024-03-13
- **Termination date:** 2026-02-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Irvine, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0367-2024

## Citation

> AI Analytics. FDA recall D-0367-2024. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0367-2024. Source: US FDA. Licensed CC0.

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