Drug product
Magic Slim capsules (Ling Zhi, Ebony, Fox-nut, Tuckahoe, Seman Pruni, Dioscoreae, Wheat Germ, Nature Substance), 60-count bottles.
D-1221-2014
Product summary
- Firm
- Slim Beauty USA
- Event
- Event 67260
- Status
- Terminated
- Classification
- Class I
- Quantity
- 2 bottles
- Official record key
drug-enforcement:D-1221-2014
Official wording
Reason: 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.
Code information: No lot code information or exp date on packaging.
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
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.