FDA recall D-0223-2017

Love My Tru Body · Class I · drug

Product

Skinny Bee Diet capsules, 500 mg, packaged in a 60-count bottle

Reason for recall

Marketed without an approved NDA/ANDA: presence of undeclared sibutramine, desmethylsibutramine (an active metabolite of sibutramine) and phenolphthalein.

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2016-10-28
Report date: 2016-12-28
Termination date: 2017-04-06
Voluntary/Mandated: Voluntary: Firm initiated
Location: McDonough, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0223-2017