Product Safety Recalls

Product Recall Tracker

BEMPEDOIC ACID Recall D-1143-2023

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

BEMPEDOIC ACID Recall D-1143-2023 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1143-2023
Event ID92897
BrandNEXLIZET
Generic NameBEMPEDOIC ACID AND EZETIMIBE
ManufacturerBEMPEDOIC ACID AND EZETIMIBE
Original Package?1
Active SubstanceBEMPEDOIC ACID EZETIMIBE
Drug RouteORAL
DistributionNationwide USA
Quantity45,240 bottles
Recall ReasonFailed dissolution specifications: below specification results at stability 12-month
Drug ClassificationClass III
Drug Code Info20230913
Product NDC72426-818
Product NUIN0000193913 N0000193914 N0000008553
Drug UPC0372426818034
Pharma Class (PE)Decreased Cholesterol Absorption [PE]
Pharma Class (EPC)Adenosine Triphosphate-Citrate Lyase Inhibitor [EPC]
Recall Initiation Date20230816
Report Date20230913
Classification Date20230906
Address3891 Ranchero Dr Ste 150
Ann Arbor, MI 48108-2837
United States
Recalling FirmEsperion
Initial Notification Letter
Unique Ingredient Identifier1EJ6Z6Q368 EOR26LQQ24
Drug Application NumberNDA211617
Structured Product Labeling (SPL ID)e5c4d988-7b4a-4050-8f93-d290d4bc804a
Structured Product Labeling (SPL Set ID)3fa2108c-0300-47b8-9d34-f762af7c93c6
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