FDA Recall D-1222-2014
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
Dream Body Slimming Capsule (Chinese bitter orange 24%, Cassia Seed 18%, Aloe 16%, Lotus Leaf Extract 12%, Medical Amylum 30%), 350 mg, 30-count bottles, Made in China (Beijing).
Reason for recall
Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine and . Sibutramine is not currently marketed in the United States, making this product an unapproved new drug.
Recall record
- Recall number
D-1222-2014- 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