Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Orient Pharma Co., Ltd. Yunlin Plant | Yunlin County, Taiwan | Makes it | No problems foundMay 23, 2025 · 4 inspections |
Recalls
- Jun 11, 2025 · Class III · Orient Pharma Co., Ltd. Yunlin Plant
Failed Impurities/Degradation Specifications.
Lots: P061001, P061002, P061003, P061004, P061006 & P061007 Exp Date 07/2025; P061008, Exp Date 08/2025; P061009 & P061010 Exp Date 10/2025; P061011, P061012 & P061013 Exp Date 01/2026; P061016, P061017 & P061018, Exp Date 04/2026; P061019, Exp Date 05/2026; P061023, Exp Date 01/2027. - Jun 11, 2025 · Class III · Orient Pharma Co., Ltd. Yunlin Plant
Failed Impurities/Degradation Specifications.
Lots: P051001, P051002, & P051003, Exp Date 07/2025; P051005, Exp Date 10/2025; P051006, Exp Date 10/2025; P051007, Exp Date 01/2026; P051010, Exp Date 07/2026; P051011 & P051012, Exp Date 09/2026; P051013, P051014 and P051015, Exp Date 01/2027.
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
- 1.045 mg
- Approval
- ANDA ANDA205932
- On the market since
- Nov 2, 2023
- Package NDCs
0480-3631-98- Official label
- DailyMed (National Library of Medicine), updated May 23, 2024
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