Drug 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
D-1143-2023
Product summary
- Firm
- Esperion
- Event
- Event 92897
- Status
- Completed
- Classification
- Class III
- Quantity
- 45,240 bottles
- Official record key
drug-enforcement:D-1143-2023
Official wording
Reason: Failed dissolution specifications: below specification results at stability 12-month
Code information: Lot# 1904872, Exp 1/31/2025; 1950377, Exp 6/30/2025
Distribution pattern: Nationwide USA
Derived failure modes
-
Potency or specification failure
Failed dissolution specifications