# FDA recall D-1659-2012

> **Prometheus Laboratories Inc.** · Class II · drug recall initiated 2012-06-29.

## Product

Mercaptopurine Tablets, USP, 50 mg, packaged in a) 60-count tablets per bottle (NDC 49884-922-02) and b) 250-count tablets per bottle (NDC 49884-922-04), Rx only, Distributed by: Par Pharmaceutical Companies, Inc., Spring Valley, NY  10977.

## Reason for recall

Failed USP Dissolution Test Requirements: The recalled lots do not meet the specification for dissolution.

## Distribution

Nationwide and Puerto Rico.

## Key facts

- **Recall number:** D-1659-2012
- **Recalling firm:** Prometheus Laboratories Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2012-06-29
- **Report date:** 2012-08-29
- **Termination date:** 2013-03-27

- **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-1659-2012

## Citation

> AI Analytics. FDA recall D-1659-2012. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-1659-2012. Source: US FDA. Licensed CC0.

---

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