D-1220-2014 Class I Terminated
FDA drug recall D-1220-2014 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. Sibutramine and phenolphthalein are not currently marketed in the United States, making this pro… The recall status is terminated (terminated March 14, 2017). Affected quantity: 4 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
- 4 bottles
Product Description
Dr. Ming's Chinese Capsule (Ginger 50 mg, Camellia Sinensis 50 mg, Malus Domestica 50 mg, Propetary Blend 300 mg Cynara Scolymus, Hoodia, Siruline, Chitosan, 60-count bottles, Distributed by Natural Products, Doral, FL 33178.
Reason for Recall
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
Lot #: 18 04 12, Exp 17 04 14