FDA Recall D-1594-2014
Nature's Universe · Nashville, TN
Class I — life-threatening Terminated 366 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
THINOGENICS, WEIGHT LOSS MADE EASY! DIETARY SUPPLEMENT, 30 CAPSULES, 30 Count Bottles, THINOGENICS LLC, Nashville, TN 37203 USA.
Reason for recall
Marketed Without an Approved NDA/ANDA: Product contains undeclared sibutramine.
Recall record
- Recall number
D-1594-2014- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- U.S. Nationwide and Canada
- Recall initiated
- 2014-04-09
- Classified by FDA Center
- 2014-09-18
- FDA published
- 2014-09-24
- Terminated
- 2015-04-10
- Recalling firm
- Nature's Universe
- Firm location
- Nashville, TN