Drug 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
D-0258-2025
Product summary
- Event
- Event 96379
- Status
- Completed
- Classification
- Class III
- Quantity
- 5,328 Bottles
- Official record key
drug-enforcement:D-0258-2025
Official wording
Reason: Presence of foreign tablets/capsules
Code information: Lot#: 3231300, Exp 8/2027
Distribution pattern: PA, OH, and TX
Derived failure modes
-
Foreign material or chemical contamination
foreign tablets