Recalls / Class III
Class IIID-0441-2024
Product
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
- Brand name
- Nexlizet
- Generic name
- Bempedoic Acid And Ezetimibe
- Active ingredients
- Bempedoic Acid, Ezetimibe
- Route
- Oral
- NDC
- 72426-818
- FDA application
- NDA211617
- Affected lot / code info
- Lot #, 1990305, Exp 08-31-2025
Why it was recalled
Failed dissolution specifications: out-of-specification bempedoic acid dissolution at the 0-month timepoint.
Recalling firm
- Firm
- Esperion
- Manufacturer
- Esperion Therapeutics, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 3891 Ranchero Dr Ste 150, Ann Arbor, Michigan 48108-2837
Distribution
- Quantity
- 3,480 30-count bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2024-03-27
- FDA classified
- 2024-04-12
- Posted by FDA
- 2024-04-24
- Status
- Completed
Source: openFDA Drug Enforcement endpoint. Recall record D-0441-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.