Esperion: Drug Recall
Recall #D-0441-2024 · 03/27/2024
Class III: Low Risk
Recall Details
- Recall Number
- D-0441-2024
- Classification
- Class III
- Product Type
- Drug
- Recalling Firm
- Esperion
- Status
- Completed
- Date Initiated
- 03/27/2024
- Location
- Ann Arbor, MI, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,480 30-count bottles
Reason for Recall
Failed dissolution specifications: out-of-specification bempedoic acid dissolution at the 0-month timepoint.
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
Distribution Pattern
Nationwide in the USA
Other Recalls by Esperion
- Class III: Low Risk 08/16/2023
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.