Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Failed dissolution specifications: out-of-specification bempedoic acid dissolution at the 0-month timepoint.
NEXLIZET (bempedoic acid and ezetimibe) tablets, 180 mg/10 mg, 30-count bottle, Rx only, Manufactured for: Esperion Therapeutics, Ann Arbor, MI 48108, NDC 72426-818-03
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 Impurities/Degradation Specifications: Out of Specification (OOS) for related substances test for Anhydro Simvastatin at the 06-month time…
Reason Failed dissolution specifications: below specification results at stability 12-month
Reason Failed Excipient Specification; product manufactured using an excipient found to be OOS for conductivity
Reason Failed Excipient Specifications and Presence of Foreign Tablets/Capsules; product manufactured using an excipient found to be OOS for conductivity…
Reason Failed Excipient Specifications and Presence of Foreign Tablets/Capsules; product manufactured using an excipient found to be OOS for conductivity…
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