Drug Enforcement D-0258-2025

Presence of foreign tablets/capsules

Status

Ongoing

Classification

Class III

Report Date

March 19, 2025

Termination Date

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Product Information

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
Product quantity
5,328 Bottles
Reason for recall
Presence of foreign tablets/capsules
Recall initiation reason
—
Initial firm notification
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Distribution pattern
PA, OH, and TX

Location & Firm

Recalling firm
Kowa Pharmaceuticals America
Address
530 Industrial Park Blvd

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0258-2025
Event ID
96379
Recall initiation date
February 24, 2025
Center classification date
March 7, 2025
Code info
Lot#: 3231300, Exp 8/2027
More code info
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