FDA Recall D-1165-2016

XTREME Z DISTRIBUTORS INC · Aventura, FL

Class I — life-threatening Ongoing 3969 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death. Distribution is nationwide and the recall remains in progress.

Product

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

Lot / code: Lot 1220062085, Exp. 09/16

Quantity: 70,350 capsules

Reason for recall

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

Recall record

Recall number: D-1165-2016
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution: Nationwide
Recall initiated: 2015-07-02
Classified by FDA Center: 2016-07-06
FDA published: 2016-07-13
Recalling firm: XTREME Z DISTRIBUTORS INC
Firm location: Aventura, FL

Operational response

A Class I recall indicates a strong likelihood of serious adverse health consequence or death. Pull affected lots from active dispensing immediately. Segregate inventory in a marked, locked location pending destruction or return. If product has already been dispensed, identify affected patients and contact them by your standard recall-notification protocol.

For the official FDA enforcement record, see FDA's Recall Search.

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