Home / Recalls / Shionogi Inc. / D-1398-2012

D-1398-2012 Class II Terminated

Recalled by Shionogi Inc. — Alpharetta, GA

Recall Details

Product Type
Drugs
Report Date
July 4, 2012
Initiation Date
March 8, 2012
Termination Date
February 7, 2013
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
7230 bottles

Product Description

Nisoldipine Extended Release Tablets, 17mg, 100 count bottle, Rx only, Manufactured for: Prasco Laboratories Mason OH 45040, Manufactured by SkyePharma production SAS 38297, Saint Quentin-Pallavier, France, NDC: 0677-1979-01

Reason for Recall

Failed USP Dissolution Test Requirements: Out of Specification dissolution result at 18 month time point

Distribution Pattern

PA

Code Information

Lot number: 2021956, Exp; 01/2013

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-0982-2017 Class III — PONSTEL (Mefanamic Acid) USP, 250 mg capsules, 30-count bottles, Rx Only, Manufa (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)