D-0441-2024 Class III
FDA drug recall D-0441-2024 was initiated by Esperion on Mar 27, 2024 and is designated Class III. Reason for recall: Failed dissolution specifications: out-of-specification bempedoic acid dissolution at the 0-month timepoint. Affected quantity: 3,480 30-count bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Apr 24, 2024
- Initiation Date
- Mar 27, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,480 30-count bottles
Product description
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
Reason for recall
Failed dissolution specifications: out-of-specification bempedoic acid dissolution at the 0-month timepoint.
Distribution pattern
Nationwide in the USA
Code information
Lot #, 1990305, Exp 08-31-2025
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0441-2024
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026