FDA Recall D-1378-2014
MyNicNaxs, Inc. · Deltona, FL
Class I — life-threatening Terminated 2077 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
Slim Xtreme Weight loss capsules, 500 mg, supplied in 30 count bottles, Another product from Globe All Wellness, LLC Hollywood, FL 33020, distributed by MyNicKnaxs, LLC Deltona, FL
Reason for recall
Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredient: N-desmethylsibutramine, benzylsibutramine, and sibutramine
Recall record
- Recall number
D-1378-2014- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Distribution
- Nationwide
- Recall initiated
- 2014-01-24
- Classified by FDA Center
- 2014-06-12
- FDA published
- 2014-06-18
- Terminated
- 2019-10-02
- Recalling firm
- MyNicNaxs, Inc.
- Firm location
- Deltona, FL