Recalling firm
Esperion
Product type
Drug
Status
Completed
Report date
2024-04-24
Distribution
Nationwide in the USA
Firm state
MI
Product quantity
3,480 30-count bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & QualificationReason for recall
Failed dissolution specifications: out-of-specification bempedoic acid dissolution at the 0-month timepoint.
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
Code / lot info
Lot #, 1990305, Exp 08-31-2025
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.