Drug recall D-0981-2017

Class III Terminated reported Jul 26, 2017

Product

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

Lots and codes

Lot #: 5H66200103G, Exp. June 2018.

Recall details

Recalling firm
Shionogi Inc., Alpharetta, GA
Quantity
6304 bottles
Distribution
Nationwide
Type
Voluntary: Firm initiated
Recall initiated
May 24, 2017
Terminated
February 28, 2018