Esperion: Drug Recall

Recall #D-1143-2023 · 08/16/2023

Class III: Low Risk

Recall Details

Recall Number
D-1143-2023
Classification
Class III
Product Type
Drug
Recalling Firm
Esperion
Status
Completed
Date Initiated
08/16/2023
Location
Ann Arbor, MI, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
45,240 bottles

Reason 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

Distribution Pattern

Nationwide USA

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.