Drug recall D-0258-2025
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
Reason for recall
Presence of foreign tablets/capsules
Lots and codes
Lot#: 3231300, Exp 8/2027
Recall details
- Recalling firm
- Kowa Pharmaceuticals America, Montgomery, AL
- Quantity
- 5,328 Bottles
- Distribution
- PA, OH, and TX
- Type
- Voluntary: Firm initiated
- Recall initiated
- February 24, 2025
Related products
- Livalo – drug information
- NDC 66869-104 Livalo · Pitavastatin Calcium 1.045 mg/1 · Kowa Pharmaceuticals America, Inc.
- NDC 66869-404 Livalo · Pitavastatin Calcium 4.18 mg/1 · Kowa Pharmaceuticals America, Inc.
- NDC 66869-204 Livalo · Pitavastatin Calcium 2.09 mg/1 · Kowa Pharmaceuticals America, Inc.