FDA Recall Terminated Historical recordClass III
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
- Failed Dissolution Specifications
- Published
- August 12, 2015
- Distribution
- Nationwide
