D-1143-2023 Class III
FDA drug recall D-1143-2023 was initiated by Esperion on August 16, 2023 and is designated Class III. Reason for recall: Failed dissolution specifications: below specification results at stability 12-month Affected quantity: 45,240 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- September 13, 2023
- Initiation Date
- August 16, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 45,240 bottles
Product Description
Nexlizet (bempedoic acid and ezetimibe), 180ng/18mg, 30 tablets, Rx only, Manufactured for: Esperion Therapeutics, Inc, Ann Arbor, MI 48108, NDC 72426-818-03
Reason for Recall
Failed dissolution specifications: below specification results at stability 12-month
Distribution Pattern
Nationwide USA
Code Information
Lot# 1904872, Exp 1/31/2025; 1950377, Exp 6/30/2025