Recalling firm
Kowa Pharmaceuticals America
Product type
Drug
Status
Completed
Report date
2025-03-19
Distribution
PA, OH, and TX
Firm state
AL
Product quantity
5,328 Bottles
Initiated by
Voluntary: Firm initiated
Reason for recall
Presence of foreign tablets/capsules
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
Code / lot info
Lot#: 3231300, Exp 8/2027
Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.