US Drug Recall Register
Class III · Low risk Terminated Initiated May 24, 2017 (9 years ago)

PONSTEL (Mefanamic Acid) USP, 250 mg capsules, 30-count bottles, Rx Only, Manufactured…

Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.

Why it was recalled

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

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

Recalling firm
Shionogi Inc.
Origin
GA, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0982-2017

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.