FDA Recall D-1221-2014

Slim Beauty USA · Kearney, NE

Class I — life-threatening Terminated 1190 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.

Product

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

Lot / code: No lot code information or exp date on packaging.

Quantity: 2 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.

Recall record

Recall number: D-1221-2014
Classification: Class I
Status: Terminated
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: E-Mail
Distribution: Nationwide
Recall initiated: 2013-12-10
Classified by FDA Center: 2014-04-07
FDA published: 2014-04-16
Terminated: 2017-03-14
Recalling firm: Slim Beauty USA
Firm location: Kearney, NE

‹ All recalls