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
Recall Number: D-1398-2012
Firm: Shionogi Inc.
Classification: Class II
Status: Terminated
Report Date: 20120704
Initiation Date: 20120308
Termination Date: 20130207
Reason for Recall
Failed USP Dissolution Test Requirements: Out of Specification dissolution result at 18 month time point
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