NDC 12634-516
Phentermine Hydrochloride 30 mg capsule
On the label: Apotheca, Inc.. It's repackaged: Apotheca, Inc. rebottles it from KVK-TECH, Inc.'s NDC 10702-028.
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
- Apotheca Inc., Phoenix, AZ, United States · repackages it and relabels 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
- 30 mg
- Approval
- ANDA ANDA040875
- On the market since
- Aug 7, 2012
- Package NDCs
12634-516-0012634-516-0112634-516-0912634-516-4012634-516-4212634-516-4512634-516-5012634-516-5212634-516-5412634-516-5712634-516-5812634-516-59- Official label
- DailyMed (National Library of Medicine), updated Jun 27, 2016
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