Nexlizet (bempedoic acid and ezetimibe), 180ng/18mg, 30 tablets, Rx only, Manufactured for: Esperion Therapeutics, Inc,
Summary
The FDA issued a Class III for Nexlizet (bempedoic acid and ezetimibe), 180ng/18mg, 30 tablets, Rx only, Manufa by Esperion. Reason: Failed dissolution specifications: below specification results at stability 12-month.
Details
Source
Drug Recall
External ID
D-1143-2023
Action Date
2023-09-13
Status
Completed
Category
drug
Product 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
Lot/Code Info: Lot# 1904872, Exp 1/31/2025; 1950377, Exp 6/30/2025
Quantity Affected: 45,240 bottles
Reason for Recall
Failed dissolution specifications: below specification results at stability 12-month
Distribution
Nationwide USA
Type: Voluntary: Firm initiated
Recall Initiated: 2023-08-16
Company
Ann Arbor, MI
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 65 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Esperion has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Esperion) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Esperion have FDA actions?
Esperion has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-1143-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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