# FDA recall D-1165-2016

> **XTREME Z DISTRIBUTORS INC** · Class I · drug recall initiated 2015-07-02.

## Product

Zero Xtreme High Performance Fat Burner capsules, 30-count bottle, Distributed by Xtreme Z Distributors, Inc., Miami, FL 33180

## Reason for recall

Marketed Without an Approved NDA/ANDA: FDA sampling and analysis confirmed the presence of sibutramine and desmethylsibutramine.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-1165-2016
- **Recalling firm:** XTREME Z DISTRIBUTORS INC
- **Classification:** Class I
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2015-07-02
- **Report date:** 2016-07-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Aventura, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1165-2016

## Citation

> AI Analytics. FDA recall D-1165-2016. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/D-1165-2016. Source: US FDA. Licensed CC0.

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