Shionogi Inc. recalls Mefenamic Acid, 250mg capsules, packaged in 30-count bottles, Rx Only, Distributed by: Prasco Laboratories Mason, OH 45…

Recall date

May 24, 2017

Source

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

Recall number

D-0981-2017

FDA classification

Class III

Brand / firm

Shionogi Inc.

Sold / distributed

Nationwide

Why it was recalled

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

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

What was recalled

Mefenamic Acid, 250mg capsules, packaged in 30-count bottles, Rx Only, Distributed by: Prasco Laboratories Mason, OH 45040 USA, Manufactured by: Halo Pharmaceutical Inc. Whippany, NJ 07981, NDC 66993-070-30