FDA Recall D-0664-2016

Life and More LLC · Doral, FL

Class I — life-threatening Ongoing 3958 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

Akttive High Performance Fat Burner Gold dietary supplement capsules, 30-count bottle, Distributed by Life and More, L.L.C., Doral, Florida

Lot / code: Lot # 000815004400; Exp 12/17

Quantity: 783 bottles

Reason for recall

Marketed Without An Approved NDA/ANDA: Dietary supplements contains undeclared sibutramine, desmethylsibutramine and phenolphthalein based on FDA sampling.

Recall record

Recall number: D-0664-2016
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: E-Mail
Distribution: Nationwide and Colombia, South America
Recall initiated: 2015-07-13
Classified by FDA Center: 2016-02-12
FDA published: 2016-02-24
Recalling firm: Life and More LLC
Firm location: Doral, 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.

‹ All recalls