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

Recall Number: D-0441-2024

Firm: Esperion

Classification: Class III

Status: Completed

Report Date: 20240424

Initiation Date: 20240327

Termination Date:

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