FDA Recall D-1231-2014
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 Fortune capsules Dietary Supplement. Each bottle contains 30 capsules.
Reason for recall
Marketed Without an Approved NDA/ANDA; product found to contain undeclared sibutramine
Recall record
- Recall number
D-1231-2014- 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