Kowa Pharmaceuticals America: Drug Recall
Recall #D-0258-2025 · 02/24/2025
Class III: Low Risk
Recall Details
- Recall Number
- D-0258-2025
- Classification
- Class III
- Product Type
- Drug
- Recalling Firm
- Kowa Pharmaceuticals America
- Status
- Completed
- Date Initiated
- 02/24/2025
- Location
- Montgomery, AL, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5,328 Bottles
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
Distribution Pattern
PA, OH, and TX
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.