NDC 33261-994
Alfuzosin Hydrochloride 10 mg tablet, extended release
On the label: Aidarex Pharmaceuticals LLC. It's repackaged: Aidarex Pharmaceuticals LLC 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 |
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
- Nov 22, 2011
- Package NDCs
33261-994-3033261-994-6033261-994-90- Official label
- DailyMed (National Library of Medicine), updated Nov 14, 2013
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