Zydus Lifesciences Limited
Ahmedabad, India · makes it and tests it
Problems found, fixed voluntarily Last FDA inspection Aug 5, 2022. 10 inspections on record, 3 with serious problems.
NDC 50436-3933
Paroxetine 20 mg tablet, film coated
On the label: Unit Dose Services.
It's a repackaged product: Unit Dose Services rebottles it from Zydus Pharmaceuticals (USA) Inc.'s NDC 68382-098.
Where the pills inside were made
Zydus Lifesciences Limited
Solan, India · makes it and tests it
No problems found Last FDA inspection Mar 9, 2020. 6 inspections on record.
Repackaging site
- Unit Dose Services, · repackages it and relabels it
Recalls
- Nov 20, 2017 · Class II · Terminated
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 · Terminated
Presence of Foreign tablets/capsules: risperidone Tablets were found in bottle of paroxetine Tablets
Lots: Lot #: Z701133, Exp 03/19
Product details
- Generic drug
- Paroxetine: see every company that makes it
- Form
- tablet, film coated
- Strength
- 20 mg
- Approval
- ANDA ANDA077584
- On the market since
- Apr 13, 2007
- Package NDCs
50436-3933-3- Official label
- DailyMed (National Library of Medicine), updated Nov 7, 2017
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