FDA recall D-1331-2014

Herbal Give Care Llc · Class I · drug

Product

Esbelder Siloutte Suplemento Alimenticio, 30 capsule bottle, Hecho en Mexico Por: Herbal Give Care, Av Independencia # 1016, Fracc. La Rinconada, Aguascalientes, Ags. Mex. C.P. 20136. UPC 7502011000268

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-1331-2014