FDA recall D-0258-2025

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

Reason for recall

Presence of foreign tablets/capsules

Distribution

PA, OH, and TX

Key facts

Status

Completed

Initiation date

2025-02-24

Report date

2025-03-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Montgomery, AL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0258-2025