Drug recall D-0982-2017

Class III Terminated reported Jul 26, 2017

Product

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

Reason for recall

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

Lots and codes

Lot #: 5H66200103, Exp. June 2018

Recall details

Recalling firm
Shionogi Inc., Alpharetta, GA
Quantity
455 bottles
Distribution
Nationwide
Type
Voluntary: Firm initiated
Recall initiated
May 24, 2017
Terminated
February 28, 2018