Drug Enforcement D-1143-2023

Failed dissolution specifications: below specification results at stability 12-month

Status

Completed

Classification

Class III

Report Date

September 13, 2023

Termination Date

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Product Information

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
Product quantity
45,240 bottles
Reason for recall
Failed dissolution specifications: below specification results at stability 12-month
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
Nationwide USA

Location & Firm

Recalling firm
Esperion
Address
3891 Ranchero Dr Ste 150, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-1143-2023
Event ID
92897
Recall initiation date
August 16, 2023
Center classification date
September 6, 2023
Code info
Lot# 1904872, Exp 1/31/2025; 1950377, Exp 6/30/2025
More code info
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