FDA recall D-1378-2014

Product

Slim Xtreme Weight loss capsules, 500 mg, supplied in 30 count bottles, Another product from Globe All Wellness, LLC Hollywood, FL 33020, distributed by MyNicKnaxs, LLC Deltona, FL

Reason for recall

Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredient: N-desmethylsibutramine, benzylsibutramine, and sibutramine

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2014-01-24

Report date

2014-06-18

Termination date

2019-10-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

Deltona, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1378-2014