FDA Recall D-0878-2016
Centro Naturista · Dallas, TX
Class I — life-threatening Terminated 666 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
Smart Lipo Dietary Supplement capsules, 900 mg, packaged in 30-count plastic bottle, Distributed by: SmartLipo365, Arlington, TX 76011
Reason for recall
Marketed without an approved NDA/ANDA - Product contains undeclared sibutramine, desmethylsibutramine and phenolphthalein.
Recall record
- Recall number
D-0878-2016- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Nationwide
- Recall initiated
- 2015-06-03
- Classified by FDA Center
- 2016-05-26
- FDA published
- 2016-06-01
- Terminated
- 2017-03-30
- Recalling firm
- Centro Naturista
- Firm location
- Dallas, TX