FDA recall D-0441-2024

Product

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

Nationwide in the USA

Key facts

Status

Completed

Initiation date

2024-03-27

Report date

2024-04-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Ann Arbor, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0441-2024