Drug Recall: 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 Pharmaceutica
Kowa Pharmaceuticals America · February 24, 2025
Reason for Recall
Presence of foreign tablets/capsules
Product Description
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
Distribution
PA, OH, and TX
States Affected
OH, PA, TX
Quantity Affected
5,328 Bottles
Source: FDA (openFDA Drug Enforcement)
Recall number: D-0258-2025
Status: completed
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