NEXLIZET (bempedoic acid and ezetimibe) tablets, 180 mg/10 mg, 30-count bottle, Rx only, Manufact...
FDA Recall #D-0441-2024 — Class III — March 27, 2024
Product Description
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
Reason for Recall
Failed dissolution specifications: out-of-specification bempedoic acid dissolution at the 0-month timepoint.
Recalling Firm
Esperion — Ann Arbor, MI
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
3,480 30-count bottles
Distribution
Nationwide in the USA
Code Information
Lot #, 1990305, Exp 08-31-2025
Status
Completed
Voluntary / Mandated
Voluntary: Firm initiated