FDA recall D-1207-2015

Bethel Nutritional Consulting, Inc · Class I · drug

Product

SLIM-K, 30 Capsules, barcode 160126417509, Distributed by: Bethel Inc.

Reason for recall

Marketed Without An Approved NDA/ANDA: Product was found to contain sibutramine, desmethylsibutramine and phenolphthalein based on FDA sampling and analysis.

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2014-12-19
Report date: 2015-07-15
Termination date: 2018-06-27
Voluntary/Mandated: Voluntary: Firm initiated
Location: New York, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1207-2015