FDAHealthFebruary 24, 2025
Kowa Pharmaceuticals America — 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,
⚠️ Presence of foreign tablets/capsules
Is this relevant to me?
- Geography
- PA, OH, TX
- Source agency
- FDA
- Category
- Health
- Published
- February 24, 2025
PA, OH, and TX
What's affected?
- Product
- 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
- Brand
- LIVALO
- UPC
- 0366869204905
- Lot code
- 3231300
Additional details
Lot#: 3231300, Exp 8/2027
What should I do?
Recommended action
Class III recall. Voluntary: Firm initiated Quantity affected: 5,328 Bottles.
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