FDA recall D-1165-2016

XTREME Z DISTRIBUTORS INC · Class I · drug

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

Status
Ongoing
Initiation date
2015-07-02
Report date
2016-07-13
Voluntary/Mandated
Voluntary: Firm initiated
Location
Aventura, FL, United States

Primary source

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