# FDA recall D-0249-2015

> **Prometheus Laboratories Inc.** · Class II · drug recall initiated 2014-10-22.

## Product

Mercaptopurine Tablets, USP 50mg, a) 60-count bottle (NDC 49884-922-02), b)  250-count bottle (NDC 49884-922-04), RX only, Manufactured by Stason Pharmaceuticals, Inc., 11 Morgan, Irvine, CA 92618 for Prometheus Laboratories, Inc., 9410 Carroll Park Drive, San Diego, CA 92121

## Reason for recall

Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0249-2015
- **Recalling firm:** Prometheus Laboratories Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2014-10-22
- **Report date:** 2014-11-26
- **Termination date:** 2016-02-18

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0249-2015

## Citation

> AI Analytics. FDA recall D-0249-2015. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/D-0249-2015. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*