US Drug Recall Register
Class II · Moderate risk Terminated Initiated Mar 15, 2021 (5 years ago)

Livalo (pitavastatin) tablets 2 mg* Rx Only NdC 66869-204-90 Manufactured under license…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

What was recalled

Livalo (pitavastatin) tablets 2 mg* Rx Only NdC 66869-204-90 Manufactured under license from: Kowa Company, Limited Tokyo 103-8433 Japan Tablets Manufactured by: Patheon, Inc. Cincinnati, OH 45237 USA or by Kowa Company, Ltd Nagoya 462-0024 Japan

Recalling firm
Cardinal Health Inc.
NDC code
66869-204-90
Origin
OH, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0500-2021

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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