FDA recall D-1333-2014

Product

Esbelder Fem Mezcla con L-Carnitina Suplemento Alimenticio,30 capsule bottle, Hecho en Mexico: Soluciones HGC S. de R.L. de C.V. Av. Independencia #1060 Fracc. La Rinconada, Aguascalientes, Ags. Mex. C.P. 20136. UPC 7502011000251

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-1333-2014