NDC 0615-8219
oxybutynin 5 mg tablet, film coated, extended release
On the label: NCS HealthCare of KY, Inc dba Vangard Labs. It's repackaged: NCS HealthCare of KY, Inc dba Vangard Labs rebottles it from Zydus Pharmaceuticals (USA) Inc.'s NDC 68382-255.
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 |
Repackaging site
- NCS HealthCare of KY, LLC dba Vangard Labs, Glasgow, KY, United States · repackages it
Recalls
- Oct 19, 2023 · Class II · Zydus Pharmaceuticals (USA) Inc
Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
Lots: M212749, exp. date 11/2024; M214477, exp. date 11/2024; M214478, exp. date 11/2024; M214479, exp. date 11/2024; M214480, exp. date 11/2024 - Oct 19, 2023 · Class II · Zydus Pharmaceuticals (USA) Inc
Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
Lots: M213318, exp. date 11/2024; M213314, exp. date 11/2024; M213315, exp. date 11/2024; M214436, exp. date 11/2024; M214437, exp. date 11/2024; M214438, exp. date 11/2024; M300653, exp. date 12/2024; M300654, exp. date 12/2024 - Oct 19, 2023 · Class II · Zydus Pharmaceuticals (USA) Inc
Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
Lots: M211541, exp. date 10/2024 M211542, exp. date 10/2024 M212746, exp. date 10/2024 M300660, exp. date 12/2024 - Sep 21, 2023 · Class II · Zydus Pharmaceuticals (USA) Inc
Failed Dissolution Specifications
Lots: Lot#: M300652 and M300651, exp. Dec 2024
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, film coated, extended release, oral
- Strength
- 5 mg
- Approval
- ANDA ANDA202332
- On the market since
- Aug 10, 2017
- Package NDCs
0615-8219-39- Official label
- DailyMed (National Library of Medicine), updated Aug 12, 2024
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