Drug Enforcement D-0441-2024

Failed dissolution specifications: out-of-specification bempedoic acid dissolution at the 0-month timepoint.

Status

Completed

Classification

Class III

Report Date

April 24, 2024

Termination Date

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Product Information

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
Product quantity
3,480 30-count bottles
Reason for recall
Failed dissolution specifications: out-of-specification bempedoic acid dissolution at the 0-month timepoint.
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
Esperion
Address
3891 Ranchero Dr Ste 150

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

Codes & Dates

Recall number
D-0441-2024
Event ID
94365
Recall initiation date
March 27, 2024
Center classification date
April 12, 2024
Code info
Lot #, 1990305, Exp 08-31-2025
More code info
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