Shionogi Inc. recalls PONSTEL (Mefanamic Acid) USP, 250 mg capsules, 30-count bottles, Rx Only, Manufactured for: Shionogi Inc. Florham Park,…

Recall date

May 24, 2017

Source

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

Recall number

D-0982-2017

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

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