Why it was recalled
Failed dissolution specifications: out-of-specification bempedoic acid dissolution at the 0-month timepoint.
Product description
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
Lot numbers, UPCs & expiration codes
Lot #, 1990305, Exp 08-31-2025
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0441-2024
- Classification
- Class III
- Status
- Completed
- Recall initiated
- Mar 27, 2024
- FDA report date
- Apr 24, 2024
- Quantity
- 3,480 30-count bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Esperion
Original FDA data
Every field from FDA enforcement report D-0441-2024, exactly as published.
Show all FDA fields
- City
- Ann Arbor
- State
- MI
- Status
- Completed
- Country
- United States
- Event ID
- 94365
- Address
- 3891 Ranchero Dr Ste 150
- Code information
- Lot #, 1990305, Exp 08-31-2025
- Postal code
- 48108-2837
- Report date
- Apr 24, 2024
- Product type
- Drugs
- Recall number
- D-0441-2024
- Classification
- Class III
- Recalling firm
- Esperion
- Product quantity
- 3,480 30-count bottles
- Reason for recall
- Failed dissolution specifications: out-of-specification bempedoic acid dissolution at the 0-month timepoint.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Mar 27, 2024
- Initial firm notification
- Letter
- Center classification date
- Apr 12, 2024