NDC 61919-316
Phentermine HCL 15 mg capsule
On the label: Direct Rx. It's repackaged: Direct Rx 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 |
Repackaging site
- Direct Rx, Dawsonville, GA, United States · repackages it
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
- Jul 8, 2016
- Package NDCs
61919-316-0761919-316-1461919-316-30- Official label
- DailyMed (National Library of Medicine), updated Apr 18, 2023
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