FDA Recall D-1233-2014
B @ B Trade Inc. · North Miami Beach, FL
Class I — life-threatening Terminated 2186 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
Slim Expert softgel capsules Dietary Supplement. One month supply/ 30 softgels. 1 softgel - 650 mg.
Reason for recall
Marketed Without an Approved NDA/ANDA; product found to contain undeclared sibutramine
Recall record
- Recall number
D-1233-2014- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Distribution
- Nationwide
- Recall initiated
- 2013-10-07
- Classified by FDA Center
- 2014-04-14
- FDA published
- 2014-04-23
- Terminated
- 2019-10-02
- Recalling firm
- B @ B Trade Inc.
- Firm location
- North Miami Beach, FL