Recalling firm
Esperion
Product type
Drug
Status
Completed
Report date
2023-09-13
Distribution
Nationwide USA
Firm state
MI
Product quantity
45,240 bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & QualificationReason for recall
Failed dissolution specifications: below specification results at stability 12-month
Product description
Nexlizet (bempedoic acid and ezetimibe), 180ng/18mg, 30 tablets, Rx only, Manufactured for: Esperion Therapeutics, Inc, Ann Arbor, MI 48108, NDC 72426-818-03
Code / lot info
Lot# 1904872, Exp 1/31/2025; 1950377, Exp 6/30/2025
Other recalls SPEQ maps to Validation & Qualification
See all Validation & Qualification recalls →Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.