NDC 16714-825
propafenone hydrochloride 225 mg capsule, extended release
On the label: Northstar Rx LLC..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Glenmark Pharmaceuticals Limited | Dhar, India | Makes it and tests it | Serious problems, FDA actionFeb 14, 2025 · 8 inspections, 1 with FDA action |
Recalls
- Mar 13, 2025 · Class II · Glenmark Pharmaceuticals Inc., USA
CGMP Deviations
Lots: Lot # 17230819, exp. date Mar-25 - Mar 13, 2025 · Class II · Glenmark Pharmaceuticals Inc., USA
CGMP Deviations
Lots: Lot # 17230767, exp. date Mar-25
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Propafenone: every company that makes it
- Form
- capsule, extended release, oral
- Strength
- 225 mg
- Approval
- ANDA ANDA205268
- On the market since
- Mar 31, 2017
- Package NDCs
16714-825-01- Official label
- DailyMed (National Library of Medicine), updated Jun 4, 2026
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