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
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1143-2023 |
| Event ID | 92897 |
| Brand | NEXLIZET |
| Generic Name | BEMPEDOIC ACID AND EZETIMIBE |
| Manufacturer | BEMPEDOIC ACID AND EZETIMIBE |
| Original Package? | 1 |
| Active Substance | BEMPEDOIC ACID EZETIMIBE |
| Drug Route | ORAL |
| Distribution | Nationwide USA |
| Quantity | 45,240 bottles |
| Recall Reason | Failed dissolution specifications: below specification results at stability 12-month |
| Drug Classification | Class III |
| Drug Code Info | 20230913 |
| Product NDC | 72426-818 |
| Product NUI | N0000193913 N0000193914 N0000008553 |
| Drug UPC | 0372426818034 |
| Pharma Class (PE) | Decreased Cholesterol Absorption [PE] |
| Pharma Class (EPC) | Adenosine Triphosphate-Citrate Lyase Inhibitor [EPC] |
| Recall Initiation Date | 20230816 |
| Report Date | 20230913 |
| Classification Date | 20230906 |
| Address | 3891 Ranchero Dr Ste 150 Ann Arbor, MI 48108-2837 United States |
| Recalling Firm | Esperion |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 1EJ6Z6Q368 EOR26LQQ24 |
| Drug Application Number | NDA211617 |
| 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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