Shionogi Inc. recalls Nisoldipine Extended Release Tablets, 17mg, 100 count bottle, Rx only, Manufactured for: Prasco Laboratories Mason OH 4
Recalled July 4, 2012 · FDA recall D-1398-2012 · Shionogi
Hazard
Failed USP Dissolution Test Requirements: Out of Specification dissolution result at 18 month time point · FDA Class II
Units
7230 bottles
Sold at
PA
Description
Failed USP Dissolution Test Requirements: Out of Specification dissolution result at 18 month time point
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
Manufacturer(s)
Shionogi Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →