# FDA recall D-0982-2017

> **Shionogi Inc.** · Class III · drug recall initiated 2017-05-24.

## Product

PONSTEL (Mefanamic Acid) USP, 250 mg capsules, 30-count bottles, Rx Only, Manufactured for: Shionogi Inc. Florham Park, NJ 07932 Manufactured by: Halo Pharmaceutical Inc. Whippany, NJ 07981

## Reason for recall

Failed Dissolution Specifications: Low dissolution results were obtained during stability testing

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0982-2017
- **Recalling firm:** Shionogi Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-05-24
- **Report date:** 2017-07-26
- **Termination date:** 2018-02-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Alpharetta, GA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0982-2017

## Citation

> AI Analytics. FDA recall D-0982-2017. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0982-2017. Source: US FDA. Licensed CC0.

---

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