NDC 61919-513
Paroxetine 40 mg tablet, film coated
On the label: Direct Rx. It's repackaged: Direct Rx rebottles it from Zydus Pharmaceuticals (USA) Inc.'s NDC 68382-001.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Zydus Lifesciences Limited | Ahmedabad, India | Makes it and tests it | Problems found, fixed voluntarilyAug 5, 2022 · 10 inspections, 3 with FDA action |
| Zydus Lifesciences Limited | Solan, India | Makes it and tests it | No problems foundMar 9, 2020 · 6 inspections |
Repackaging site
- Direct Rx, Dawsonville, GA, United States · repackages it
Recalls
- Nov 20, 2017 · Class II · Zydus Pharmaceuticals USA Inc
Presence of Foreign Tablets/Capsules: Risperidone Tablets were found in bottle of Paroxetine Tablets
Lots: a) Z701308, b) Z701309, c) Z701310 exp April 2019 - Aug 18, 2017 · Class II · Zydus Pharmaceuticals USA Inc
Presence of Foreign tablets/capsules: risperidone Tablets were found in bottle of paroxetine Tablets
Lots: Lot #: Z701133, Exp 03/19
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, oral
- Strength
- 40 mg
- Approval
- ANDA ANDA077584
- On the market since
- Feb 29, 2016
- Package NDCs
61919-513-3061919-513-90- Official label
- DailyMed (National Library of Medicine), updated Mar 5, 2026
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