NDC 68180-646
Paroxetine 25 mg tablet, film coated, extended release
On the label: Lupin Pharmaceuticals, Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Lupin Limited | Pithampur, India | Makes it and packages it | Serious problems, FDA actionJul 17, 2025 · 6 inspections, 4 with FDA action |
Recalls
- Jun 22, 2017 · Class III · Lupin Pharmaceuticals Inc.
Failed Dissolution Specifications: out of specification observed in dissolution testing at 3 month long term stability study.
Lots: Lots: H605712, H605711, H605710, EXP November 2018; H702255, H702202 EXP March 2019
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Paroxetine: every company that makes it
- Form
- tablet, film coated, extended release, oral
- Strength
- 25 mg
- Approval
- ANDA ANDA204134
- On the market since
- Mar 6, 2017
- Package NDCs
68180-646-0168180-646-0268180-646-0368180-646-06- Official label
- DailyMed (National Library of Medicine), updated Oct 31, 2023
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