D-0258-2025 Class III
Recall Details
- Product Type
- Drugs
- Report Date
- March 19, 2025
- Initiation Date
- February 24, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5,328 Bottles
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
Distribution Pattern
PA, OH, and TX
Code Information
Lot#: 3231300, Exp 8/2027