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D-1143-2023Class III

Esperion

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

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 & Qualification
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

Code / lot info

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

Data: U.S. FDA. 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. Open the enforcement explorer →