NDC 61919-349
Alfuzosin Hydrochloride 10 mg tablet, extended release
On the label: Direct Rx. It's repackaged: Direct Rx rebottles it from Caraco Pharmaceutical Laboratories, Ltd.'s NDC 47335-956.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Sun Pharmaceutical Industries Limited | Halol, India | Makes it and tests it | Serious problems, FDA actionJun 13, 2025 · 12 inspections, 5 with FDA action |
Repackaging site
- Direct Rx, Dawsonville, GA, United States · repackages it
Recalls
- Jan 5, 2017 · Class II · Sun Pharmaceutical Industries, Inc.
Presence of Foreign Substance: consumer complaint for foreign matter embedded in the tablet identified as a broken piece of wire rope from the manufacturing equipment.
Lots: Lot #: JKR5219A, JKR5200A, JKR5220A, JKR5221A, JKR5222A, Exp 03/18
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Alfuzosin: every company that makes it
- Form
- tablet, extended release
- Strength
- 10 mg
- Approval
- ANDA ANDA079057
- On the market since
- Dec 21, 2015
- Package NDCs
61919-349-30- Official label
- DailyMed (National Library of Medicine), updated Jan 17, 2020
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