Livalo (pitavatstatin) tablets, 4 mg, 90-count bottles, Rx only, Manufactured by: Patheon, Inc. C...
FDA Recall #D-0258-2025 — Class III — February 24, 2025
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
Reason for Recall
Presence of foreign tablets/capsules
Recalling Firm
Kowa Pharmaceuticals America — Montgomery, AL
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
5,328 Bottles
Distribution
PA, OH, and TX
Code Information
Lot#: 3231300, Exp 8/2027
Status
Completed
Voluntary / Mandated
Voluntary: Firm initiated