FDA Recall D-1220-2014
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
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.
Recall record
- Recall number
D-1220-2014- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- 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