Home / Recalls / Shionogi Inc. / D-0982-2017

D-0982-2017 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
455 bottles

Product Description

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

Distribution Pattern

Nationwide

Code Information

Lot #: 5H66200103, Exp. June 2018

Other recalls by Shionogi Inc.

  • D-0219-2018 Class III — Mefenamic Acid Capsules, USP, 250 mg, 30-count bottle, Rx only, Distributed by P (May 24, 2017)
  • D-0981-2017 Class III — Mefenamic Acid, 250mg capsules, packaged in 30-count bottles, Rx Only, Distribut (May 24, 2017)
  • D-1284-2015 Class III — Nisoldipine Extended Release Tablets, 17 mg, packaged as a) Sular (nisoldipine) (July 24, 2015)
  • D-1398-2012 Class II — Nisoldipine Extended Release Tablets, 17mg, 100 count bottle, Rx only, Manufact (March 8, 2012)