FDA recall D-1329-2014

Product

Esbelin Siloutte Mezcal Herbal con L-Carnitine Suplemento Alimenticio, 30 capsule bottle, Hecho En Mexico Por: Soluciones HGC S. de R.L. de C.V. Av. Independicia #1016 Frac. La Rinconada Aguascalientes, Ags. Mex C.P. 20136, UPC 7502011000060

Reason for recall

Marketed Without an Approved NDA/ANDA: Products found to contain undeclared sibutramine, N-Desmethylsibutramine, and N-di- Desmethylsibutramine. Sibutramine was removed from the U.S. market for safety reasons, making these products unapproved new drugs.

Distribution

Products were sold to distributors nationwide. Recalling firm sold some product directly to consumers.

Key facts

Status

Terminated

Initiation date

2013-07-19

Report date

2014-05-28

Termination date

2015-08-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Grand Prairie, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1329-2014