Class III
Completed
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
- Company
- Kowa Pharmaceuticals America
- Recall Initiated
- February 24, 2025
- Posted
- March 19, 2025
- Recall Number
- D-0258-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 5,328 Bottles
- Firm Location
- Montgomery, AL, United States
Reason for Recall
Presence of foreign tablets/capsules
Distribution
PA, OH, and TX
Lot / Code Info
Lot#: 3231300, Exp 8/2027
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