# FDA recall D-0574-2016

> **PD-Rx Pharmaceuticals, Inc.** · Class III · drug recall initiated 2015-07-21.

## Product

Phentermine Hydrochloride Capsules, USP, 15 mg, packaged in  a) 7-count (NDC 55289-791-07), b) 14-count (NDC 55289-791-14), c) 28-count (NDC 55289-791-28), d) 30-count (NDC 55289-791-30), and e) 60-count (NDC 55289-791-60) bottles, Packaged by PD-RX Pharmaceuticals, INC Oklahoma City, OK 73127, MFG: KVK-TECH, INC Newtown, PA 18840.

## Reason for recall

Failed impurities/Degradation specifications: out of specification results for individual unknown and total impurity at the 12th month room temperature stability test station

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0574-2016
- **Recalling firm:** PD-Rx Pharmaceuticals, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2015-07-21
- **Report date:** 2016-01-27
- **Termination date:** 2016-12-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Oklahoma City, OK, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0574-2016

## Citation

> AI Analytics. FDA recall D-0574-2016. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/D-0574-2016. Source: US FDA. Licensed CC0.

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