Drug recall D-1398-2012

Class II Terminated reported Jul 4, 2012

Product

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

Lots and codes

Lot number: 2021956, Exp; 01/2013

Recall details

Recalling firm
Shionogi Inc., Alpharetta, GA
Quantity
7230 bottles
Distribution
PA
Type
Voluntary: Firm initiated
Recall initiated
March 8, 2012
Terminated
February 7, 2013