Reported Mar 19, 2025 · Completed
Livalo (pitavatstatin) tablets, 4 mg, 90-count bottles, Rx only, Manufactured by: Patheon, Inc. Cincinnati, OH 45237…
Kowa Pharmaceuticals America
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Kowa Pharmaceuticals America · 530 Industrial Park Blvd · Montgomery, AL · 36117-5543
Is this the product you have?
- Livalo (pitavatstatin) tablets, 4 mg, 90-count bottles, Rx only
- Manufactured byPatheon, Inc. Cincinnati, OH 45237 USA or by Kowa Company, Ltd, Nagoya, 462-0024 Japan
- Marketed by Kowa PharmaceuticalsKowa 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
- Lot codes and dates
Lot#: 3231300Exp 8/2027
- Amount recalled
- 5,328 Bottles
Where it was sold
Why it was recalled
Presence of foreign tablets/capsules
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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