Home / Recalls / Esperion / D-0441-2024

D-0441-2024 Class III

Recalled by Esperion — Ann Arbor, MI

Recall Details

Product Type: Drugs
Report Date: April 24, 2024
Initiation Date: March 27, 2024
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 3,480 30-count bottles

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.

Distribution Pattern

Nationwide in the USA

Code Information

Lot #, 1990305, Exp 08-31-2025