NDC 33261-361
Phentermine Hydrochloride 15 mg capsule
On the label: Aidarex Pharmaceuticals LLC. It's repackaged: Aidarex Pharmaceuticals LLC rebottles it from KVK-TECH, Inc.'s NDC 10702-026.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Kvk-Tech, Inc. | Newtown, PA, United States | Makes it | Serious problems, FDA actionMar 14, 2025 · 13 inspections, 3 with FDA action |
Recalls
- May 9, 2025 · Class II · KVK Tech, Inc.
cGMP deviations
Lots: Lot#: 18350A, 18351A, Exp 6/30/2027 - Aug 3, 2017 · Class III · KVK-Tech, Inc.
Failed Impurities/Degradation Specifications: out-of-specification results obtained for individual unknown impurities found at 30 month Room Temperature Retained Sample stability test.
Lots: Lot # a):12322A, 12323B, 12324A, Exp. Sep 2017; 12455A, Exp. Dec 2017; b) 12323A, Exp. Sep 2017; 12456A, Exp. Dec 2017
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Phentermine: every company that makes it
- Form
- capsule
- Strength
- 15 mg
- Approval
- ANDA ANDA040886
- On the market since
- Aug 7, 2012
- Package NDCs
33261-361-0733261-361-0833261-361-1433261-361-1533261-361-2333261-361-2833261-361-3033261-361-4033261-361-4533261-361-60- Official label
- DailyMed (National Library of Medicine), updated Oct 4, 2012
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