NDC 53808-1122
Oxybutynin Chloride 5 mg tablet
On the label: State of Florida DOH Central Pharmacy. It's repackaged: State of Florida DOH Central Pharmacy rebottles it from KVK-TECH, Inc.'s NDC 10702-201.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Kvk-Tech, Inc. | Newtown, PA, United States | Makes it | Serious problems, FDA actionMar 14, 2025 · 13 inspections, 3 with FDA action |
Repackaging site
- State of Florida DOH Central Pharmacy, Location not on file · repackages it
Recalls
- Dec 11, 2018 · Class II · KVK-Tech, Inc.
Labeling: Wrong bar code
Lots: Lot #: 15079A, Exp 10/20
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Oxybutynin: every company that makes it
- Form
- tablet
- Strength
- 5 mg
- Approval
- ANDA ANDA209335
- On the market since
- Jul 10, 2018
- Package NDCs
53808-1122-1- Official label
- DailyMed (National Library of Medicine), updated Jan 22, 2019
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