FDA recall D-1221-2014

Slim Beauty USA · Class I · drug

Product

Magic Slim capsules (Ling Zhi, Ebony, Fox-nut, Tuckahoe, Seman Pruni, Dioscoreae, Wheat Germ, Nature Substance), 60-count bottles.

Reason for recall

Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine and phenolphthalein. Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine and phenolphthalein. Sibutramine and phenolphthalein are not currently marketed in the United States, making this product an unapproved new drug.

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2013-12-10
Report date: 2014-04-16
Termination date: 2017-03-14
Voluntary/Mandated: Voluntary: Firm initiated
Location: Kearney, NE, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1221-2014