D-1221-2014 Class I Terminated
FDA drug recall D-1221-2014 was initiated by Slim Beauty USA on December 10, 2013 and is designated Class I. 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 phenolpht… The recall status is terminated (terminated March 14, 2017). Affected quantity: 2 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- April 16, 2014
- Initiation Date
- December 10, 2013
- Termination Date
- March 14, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2 bottles
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.
Distribution Pattern
Nationwide
Code Information
No lot code information or exp date on packaging.