Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Kowa Company, Ltd. | Nagoya, Japan | Makes it | No problems foundSep 1, 2023 · 3 inspections |
Recalls
- Feb 24, 2025 · Class III · Kowa Pharmaceuticals America
Presence of foreign tablets/capsules
Lots: Lot#: 3231300, Exp 8/2027 - Mar 15, 2021 · Class II · Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Lots: 3193479
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Pitavastatin: every company that makes it
- Form
- tablet, film coated, oral
- Strength
- 2.09 mg
- Approval
- NDA NDA022363
- On the market since
- May 16, 2019
- Package NDCs
66869-204-0766869-204-90- Official label
- DailyMed (National Library of Medicine), updated Mar 31, 2026
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