FDA Recall D-0675-2016
Inaffit, LLC · Gaithersburg, MD
Class I — life-threatening Terminated 161 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
NATUREAL BURN FAT NATURE, 30-count capsules, packaged in clear plastic bottle, Manufactured for: Inaffit, LLC. P.O. Box 34056, Bethesda, MD 20827.
Reason for recall
Marketed Without an Approved NDA/ANDA: Product contains undeclared sibutramine.
Recall record
- Recall number
D-0675-2016- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Distribution
- Nationwide
- Recall initiated
- 2015-10-05
- Classified by FDA Center
- 2016-02-17
- FDA published
- 2016-02-24
- Terminated
- 2016-03-14
- Recalling firm
- Inaffit, LLC
- Firm location
- Gaithersburg, MD