Shionogi Inc. recalls Mefenamic Acid Capsules, USP, 250 mg, 30-count bottle, Rx only, Distributed by Prasco Laboratories, Mason, OH 45040, Ma…

Recall date

May 24, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0219-2018

FDA classification

Class III

Brand / firm

Shionogi Inc.

Sold / distributed

U.S.A. Nationwide

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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