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

Recall Number: D-0982-2017

Firm: Shionogi Inc.

Classification: Class III

Status: Terminated

Report Date: 20170726

Initiation Date: 20170524

Termination Date: 20180228

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

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