D-0981-2017 Class III Terminated

Recalled by Shionogi Inc. — Alpharetta, GA

Recall Details

Product Type
Drugs
Report Date
July 26, 2017
Initiation Date
May 24, 2017
Termination Date
February 28, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
6304 bottles

Product Description

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

Reason for Recall

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

Distribution Pattern

Nationwide

Code Information

Lot #: 5H66200103G, Exp. June 2018.