Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Torrent Pharmaceuticals Limited | Indrad, India | Makes it | Problems found, fixed voluntarilyJun 12, 2024 · 7 inspections, 2 with FDA action |
Recalls
- Mar 15, 2021 · Class II · Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Lots: BDZ7G005 - Mar 15, 2021 · Class II · Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Lots: BDZ9G005
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Darifenacin: every company that makes it
- Form
- tablet, extended release, oral
- Strength
- 15 mg
- Approval
- ANDA ANDA205209
- On the market since
- Nov 18, 2016
- Package NDCs
13668-203-0513668-203-3013668-203-90- Official label
- DailyMed (National Library of Medicine), updated Feb 10, 2026
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