Recalls / Class III
Class IIID-1143-2023
Product
Nexlizet (bempedoic acid and ezetimibe), 180ng/18mg, 30 tablets, Rx only, Manufactured for: Esperion Therapeutics, Inc, 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# 1904872, Exp 1/31/2025; 1950377, Exp 6/30/2025
Why it was recalled
Failed dissolution specifications: below specification results at stability 12-month
Recalling firm
- Firm
- Esperion
- Manufacturer
- Esperion Therapeutics, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 3891 Ranchero Dr Ste 150, N/A, Ann Arbor, Michigan 48108-2837
Distribution
- Quantity
- 45,240 bottles
- Distribution pattern
- Nationwide USA
Timeline
- Recall initiated
- 2023-08-16
- FDA classified
- 2023-09-06
- Posted by FDA
- 2023-09-13
- Status
- Completed
Source: openFDA Drug Enforcement endpoint. Recall record D-1143-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.