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
Reported: March 19, 2025 Initiated: February 24, 2025 #D-0258-2025
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
Details
- Recalling Firm
- Kowa Pharmaceuticals America
- Units Affected
- 5,328 Bottles
- Distribution
- PA, OH, and TX
- Location
- Montgomery, AL
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Kowa Pharmaceuticals America. Units affected: 5,328 Bottles.
Why was this product recalled? ▼
Presence of foreign tablets/capsules
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 19, 2025. Severity: Low. Recall number: D-0258-2025.
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