# FDA recall D-0219-2018

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

## Product

Mefenamic Acid Capsules, USP, 250 mg, 30-count bottle, Rx only, Distributed by Prasco Laboratories, Mason, OH 45040, Manufactured by Halo Pharmaceutical Inc., Whippany, NJ 07981, NDC 66993-070-30

## Reason for recall

Presence of foreign substance: The recall was initiated due to black particles being observed while performing routine post-release stability testing on Mefenamic acid capsules

## Distribution

U.S.A. Nationwide

## Key facts

- **Recall number:** D-0219-2018
- **Recalling firm:** Shionogi Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-05-24
- **Report date:** 2018-01-24
- **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-0219-2018

## Citation

> AI Analytics. FDA recall D-0219-2018. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/D-0219-2018. Source: US FDA. Licensed CC0.

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