D-1143-2023 Class III

Recalled by Esperion — Ann Arbor, MI

Recall Details

Product Type
Drugs
Report Date
September 13, 2023
Initiation Date
August 16, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
45,240 bottles

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

Reason for Recall

Failed dissolution specifications: below specification results at stability 12-month

Distribution Pattern

Nationwide USA

Code Information

Lot# 1904872, Exp 1/31/2025; 1950377, Exp 6/30/2025