Class III
Drug Recall: 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
Esperion · March 27, 2024
Reason for Recall
Failed dissolution specifications: out-of-specification bempedoic acid dissolution at the 0-month timepoint.
Distribution
Nationwide in the USA
States Affected
NATIONWIDE
Quantity Affected
3,480 30-count bottles
Source: FDA (openFDA Drug Enforcement)
Recall number: D-0441-2024
Status: completed
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