Reported Apr 24, 2024 · Completed
NEXLIZET (bempedoic acid and ezetimibe) tablets, 180 mg/10 mg, 30-count bottle, Rx only, Manufactured for: Esperion…
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) tablets, 180 mg/10 mg, 30-count bottle, Rx only
- Manufactured forEsperion Therapeutics, Ann Arbor, MI 48108, NDC 72426-818-03
- Lot codes and dates
Lot #1990305Exp 08-31-2025
- Amount recalled
- 3,480 30-count bottles
Where it was sold
- Nationwide
Why it was recalled
Failed dissolution specifications: out-of-specification bempedoic acid dissolution at the 0-month timepoint.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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