Nexlizet (bempedoic acid and ezetimibe), 180ng/18mg, 30 tablets, Rx only, Manufactured for: Esper...
FDA Recall #D-1143-2023 — Class III — August 16, 2023
Product Description
Nexlizet (bempedoic acid and ezetimibe), 180ng/18mg, 30 tablets, Rx only, Manufactured for: Esperion Therapeutics, Inc, Ann Arbor, MI 48108, NDC 72426-818-03
Reason for Recall
Failed dissolution specifications: below specification results at stability 12-month
Recalling Firm
Esperion — Ann Arbor, MI
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
45,240 bottles
Distribution
Nationwide USA
Code Information
Lot# 1904872, Exp 1/31/2025; 1950377, Exp 6/30/2025
Status
Completed
Voluntary / Mandated
Voluntary: Firm initiated