Shionogi Inc. recalls Nisoldipine Extended Release Tablets, 17 mg, packaged as a) Sular (nisoldipine) Extended Release tablets, 100-count bot
Recalled August 12, 2015 · FDA recall D-1284-2015 · Shionogi
Hazard
Failed Dissolution Specifications · FDA Class III
Units
a) 483 bottles; b) 5,631 bottles
Sold at
Nationwide and Puerto Rico
Description
Failed Dissolution Specifications
Product
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.
Manufacturer(s)
Shionogi Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →