NDC 55289-791
Phentermine Hydrochloride 15 mg capsule
On the label: PD-Rx Pharmaceuticals, Inc.. It's repackaged: PD-Rx Pharmaceuticals, Inc. 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
- PD-Rx Pharmaceuticals Inc., Oklahoma City, OK, United States · repackages it
Recalls
- May 9, 2025 · Class II · KVK Tech, Inc.
cGMP deviations
Lots: Lot#: 18350A, 18351A, Exp 6/30/2027 - Aug 11, 2017 · Class III · PD-Rx Pharmaceuticals, Inc.
Failed Impurities/Degradation Specifications:Out of specification results for individual unknown impurities at 30th month Room Temperature Retained Sample stabilities test .
Lots: Lots: a) H15E22, Exp. 8/31/17; J15E02, Exp. 10/31/17. b) J15A53, Exp. 10/31/17; D16C78, Exp.12/31/17; c)J15D54, Exp. 10/31/17; d)H15B60, Exp. 8/31/17; e) J15A49, Exp. 10/31/17; C16A14, Exp. 12/31/17. - 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 - Jul 21, 2015 · Class III · PD-Rx Pharmaceuticals, Inc.
Failed impurities/Degradation specifications: out of specification results for individual unknown and total impurity at the 12th month room temperature stability test station
Lots: Lot #: a) H14C80, Exp 08/16; I14G36, Exp 09/16; b) H14A86, Exp 07/16; c) H14C83, Exp 08/16, K14A21, Exp 11/16; d) H14F25, Exp 08/16; e) L14C42, Exp 12/16.
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, oral
- Strength
- 15 mg
- Approval
- ANDA ANDA040886
- On the market since
- Aug 7, 2012
- Package NDCs
55289-791-0755289-791-1455289-791-1555289-791-2155289-791-2855289-791-3055289-791-60- Official label
- DailyMed (National Library of Medicine), updated Oct 20, 2025
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