August 2023 FDA Recall Nexlizet by Esperion
D-1143-2023 - Failed dissolution specifications
This Class III drug recall was voluntarily initiated by Esperion on August 16, 2023 for the product Nexlizet. The FDA reported the reason for recall as failed dissolution specifications. The product was distributed Nationwide and the recall is currently completed.
Recall Number: D-1143-2023
Failed dissolution specifications: below specification results at stability 12-month
08-16-2023
09-13-2023
45,240 bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Esperion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide USA
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# 1904872, Exp 1/31/2025; 1950377, Exp 6/30/2025
