# FDA recall D-1371-2015

> **KVK-Tech, Inc.** · Class III · drug recall initiated 2015-07-14.

## Product

Phentermine Hydrochloride Capsules, USP, 15 mg, packaged in a) 100-count bottle (NDC 10702-0026-01; UPC 3 10702 02601 8) and b) 1000-count bottle (NDC 10702-0026-10; UPC 3 10702 02601 0); Rx only, Mfd. by KVK-TECH, Inc., Newtown, PA

## 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-1371-2015
- **Recalling firm:** KVK-Tech, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2015-07-14
- **Report date:** 2015-09-02
- **Termination date:** 2017-01-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Newtown, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1371-2015

## Citation

> AI Analytics. FDA recall D-1371-2015. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/D-1371-2015. Source: US FDA. Licensed CC0.

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