FDA recall D-0664-2016

Life and More LLC · Class I · drug

Product

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

Reason for recall

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

Distribution

Nationwide and Colombia, South America

Key facts

Status
Ongoing
Initiation date
2015-07-13
Report date
2016-02-24
Voluntary/Mandated
Voluntary: Firm initiated
Location
Doral, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0664-2016