Magic Slim capsules (Ling Zhi, Ebony, Fox-nut, Tuckahoe, Seman Pruni, Dioscoreae, Wheat Germ, Nat...
FDA Recall #D-1221-2014 — Class I — December 10, 2013
Product Description
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.
Recalling Firm
Slim Beauty USA — Kearney, NE
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
2 bottles
Distribution
Nationwide
Code Information
No lot code information or exp date on packaging.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated