FDA-Drug2024-04-24Class III
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
Hazard
Failed dissolution specifications: out-of-specification bempedoic acid dissolution at the 0-month timepoint.
Sold states
Nationwide in the USA
Affected count
3,480 30-count bottles
Manufactured in
3891 Ranchero Dr Ste 150, Ann Arbor, MI, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0441-2024Don't want to check this manually?
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