Home / Recalls / Shionogi Inc. / D-1284-2015

D-1284-2015 Class III Terminated

Recalled by Shionogi Inc. — Alpharetta, GA

Recall Details

Product Type
Drugs
Report Date
August 12, 2015
Initiation Date
July 24, 2015
Termination Date
April 14, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
a) 483 bottles; b) 5,631 bottles

Product Description

Nisoldipine Extended Release Tablets, 17 mg, packaged as a) Sular (nisoldipine) Extended Release tablets, 100-count bottle (NDC 59630-501-10, UPC 3 59630 50110 5), Manufactured for: Shionogi, Inc., Florham Park, NJ 07932; and b) Nisoldipine Extended Release tablets, 100-count bottle (NDC 66993-473-02, UPC 3 6693 47302 4), Manufactured for: Prasco Laboratories, Mason, OH 45040; Rx only; Manufactured by: Aenova France SAS, 38291 Saint Quentin-Falavier, France.

Reason for Recall

Failed Dissolution Specifications

Distribution Pattern

Nationwide and Puerto Rico

Code Information

Lot #: a) 8803472, Exp 03/16; b) 8803473, Exp 03/16

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-1398-2012 Class II — Nisoldipine Extended Release Tablets, 17mg, 100 count bottle, Rx only, Manufact (March 8, 2012)