FDA recall D-1143-2023

Product

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

Distribution

Nationwide USA

Key facts

Status

Completed

Initiation date

2023-08-16

Report date

2023-09-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Ann Arbor, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1143-2023