Drug recall D-0441-2024

Class III Completed reported Apr 24, 2024

Product

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

Reason for recall

Failed dissolution specifications: out-of-specification bempedoic acid dissolution at the 0-month timepoint.

Lots and codes

Lot #, 1990305, Exp 08-31-2025

Recall details

Recalling firm
Esperion, Ann Arbor, MI
Quantity
3,480 30-count bottles
Distribution
Nationwide in the USA
Type
Voluntary: Firm initiated
Recall initiated
March 27, 2024

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