FDA Recall D-1207-2015
Bethel Nutritional Consulting, Inc · New York, NY
Class I — life-threatening Terminated 1286 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
SLIM-K, 30 Capsules, barcode 160126417509, Distributed by: Bethel Inc.
Reason for recall
Marketed Without An Approved NDA/ANDA: Product was found to contain sibutramine, desmethylsibutramine and phenolphthalein based on FDA sampling and analysis.
Recall record
- Recall number
D-1207-2015- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Nationwide
- Recall initiated
- 2014-12-19
- Classified by FDA Center
- 2015-07-06
- FDA published
- 2015-07-15
- Terminated
- 2018-06-27
- Recalling firm
- Bethel Nutritional Consulting, Inc
- Firm location
- New York, NY