Reported Sep 13, 2023 · Completed

Nexlizet (bempedoic acid and ezetimibe), 180ng/18mg, 30 tablets, Rx only, Manufactured for: Esperion Therapeutics, Inc,…

Esperion

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Esperion · 3891 Ranchero Dr Ste 150 · Ann Arbor, MI · 48108-2837

Is this the product you have?

  • Nexlizet (bempedoic acid and ezetimibe), 180ng/18mg, 30 tablets, Rx only
  • Manufactured forEsperion Therapeutics, Inc, Ann Arbor, MI 48108, NDC 72426-818-03
Lot codes and dates
    • Lot# 1904872
    • Exp 1/31/2025
    • 1950377
    • Exp 6/30/2025
Amount recalled
45,240 bottles

Where it was sold

  • Nationwide

Why it was recalled

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

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Data as of Sep 19, 6:39 PM UTC

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