# FDA recall D-1162-2017

> **Aidarex Pharmaceuticals LLC** · Class III · drug recall initiated 2017-09-05.

## Product

Phentermine, USP Capsules, 15 mg, 30 count bottles, Rx only, Packaged By: Aidarex Pharmaceuticals, Corona, CA, MFG: KVK-TECH INC. Newtown. PA --- 33261-0361-30

## Reason for recall

Failed Impurities/Degradation Specification; out-of-specification results for individual unknown impurities at the 30 month Room Temperature Retained Sample stability test

## Distribution

Distributed to the state of CA and NV.

## Key facts

- **Recall number:** D-1162-2017
- **Recalling firm:** Aidarex Pharmaceuticals LLC
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-09-05
- **Report date:** 2017-09-20
- **Termination date:** 2019-12-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Corona, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1162-2017

## Citation

> AI Analytics. FDA recall D-1162-2017. Retrieved 2026-06-08 from https://api.ai-analytics.org/recall/D-1162-2017. Source: US FDA. Licensed CC0.

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