Why it was recalled
Failed dissolution specifications: below specification results at stability 12-month
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
Lot numbers, UPCs & expiration codes
Lot# 1904872, Exp 1/31/2025; 1950377, Exp 6/30/2025
Where it was sold
Nationwide 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-1143-2023
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Aug 16, 2023
- FDA report date
- Sep 13, 2023
- Quantity
- 45,240 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Esperion
Original FDA data
Every field from FDA enforcement report D-1143-2023, exactly as published.
Show all FDA fields
- City
- Ann Arbor
- State
- MI
- Status
- Terminated
- Country
- United States
- Event ID
- 92897
- Address
- 3891 Ranchero Dr Ste 150
- Code information
- Lot# 1904872, Exp 1/31/2025; 1950377, Exp 6/30/2025
- Postal code
- 48108-2837
- Report date
- Sep 13, 2023
- Product type
- Drugs
- Recall number
- D-1143-2023
- Classification
- Class III
- Recalling firm
- Esperion
- Product quantity
- 45,240 bottles
- Termination date
- Aug 31, 2026
- Reason for recall
- Failed dissolution specifications: below specification results at stability 12-month
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide USA
- Recall initiation date
- Aug 16, 2023
- Initial firm notification
- Letter
- Center classification date
- Sep 6, 2023