WhichRecall
Class IIIReported 2025-03-19

Livalo (pitavatstatin) tablets, 4 mg, 90-count bottles, Rx only, Manufactured by: Patheon, Inc. Cincinnati, OH 45237 USA or by Kowa Company, Ltd, Nagoya, 462-0024 Japan, Marketed by Kowa Pharmaceuticals: Kowa Pharmaceuticals America Inc., Montgomery, AL 36117 USA NDC 66869-404-90 HDPE Bottle, congregated into a shrink wrapped 6-pack further congregated into 24 6-packs in a cardboard case

Recalled by Kowa Pharmaceuticals America

Reason for Recall

Presence of foreign tablets/capsules

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Recall Number
D-0258-2025
Classification
Class III
Status
Completed
Category
drug
Initiated
2025-02-24
Reported
2025-03-19
Distribution
PA, OH, and TX
Code Info
Lot#: 3231300, Exp 8/2027
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.
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