Drug 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
D-0441-2024
Product summary
- Firm
- Esperion
- Event
- Event 94365
- Status
- Completed
- Classification
- Class III
- Quantity
- 3,480 30-count bottles
- Official record key
drug-enforcement:D-0441-2024
Official wording
Reason: Failed dissolution specifications: out-of-specification bempedoic acid dissolution at the 0-month timepoint.
Code information: Lot #, 1990305, Exp 08-31-2025
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
out-of-specification