Drug & medication recalls High risk

XTREME Z DISTRIBUTORS INC recalls Zero Xtreme High Performance Fat Burner capsules, 30-count bottle, Distributed by Xtreme Z Distributors, Inc., Miami, F…

Recall date
July 2, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-1165-2016
FDA classification
Class I
Brand / firm
XTREME Z DISTRIBUTORS INC
Sold / distributed
Nationwide

Why it was recalled

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

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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

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