Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Failed Dissolution Specifications
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.
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications
Reason Lack of Assurance of Sterility
Reason Failed Impurities/Degradations Specifications
Reason Failed Dissolution Specifications: Olmesartan Medoxomil content below specifications
Reason Lack of Assurance of Sterility
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