FDA-Drug2023-09-13Class III

Nexlizet (bempedoic acid and ezetimibe), 180ng/18mg, 30 tablets, Rx only, Manufactured for: Esperion Therapeutics, Inc, Ann Arbor, MI 48108, NDC 72426-818-03

Esperion
Hazard

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

Sold states
Nationwide USA
Affected count
45,240 bottles
Manufactured in
3891 Ranchero Dr Ste 150, N/A, Ann Arbor, MI, United States
Products
Nexlizet (bempedoic acid and ezetimibe), 180ng/18mg, 30 tablets, Rx only, Manufactured for: Esperion Therapeutics, Inc, Ann Arbor, MI 48108, NDC 72426-818-03

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1143-2023

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