Livalo (pitavatstatin) tablets, 4 mg, 90-count bottles, Rx only, Manufactured by: Patheon, Inc. Cincinnati, OH 45237 USA
Summary
The FDA issued a Class III for Livalo (pitavatstatin) tablets, 4 mg, 90-count bottles, Rx only, Manufactured by by Kowa Pharmaceuticals America. Reason: Presence of foreign tablets/capsules.
Details
Source
Drug Recall
External ID
D-0258-2025
Action Date
2025-03-19
Status
Completed
Category
drug
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
Lot/Code Info: Lot#: 3231300, Exp 8/2027
Quantity Affected: 5,328 Bottles
Reason for Recall
Presence of foreign tablets/capsules
Distribution
PA, OH, and TX
Type: Voluntary: Firm initiated
Recall Initiated: 2025-02-24
Company
Montgomery, AL
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 61 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Kowa Pharmaceuticals America) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Kowa Pharmaceuticals America have FDA actions?
This is the only FDA action we have on record for Kowa Pharmaceuticals America in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0258-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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