FDA Recall D-1351-2014
Deseo Rebajar · Fajardo, PR
Class I — life-threatening Terminated 1227 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
Burn 7 Capsules, supplied in 30 capsules bottle
Reason for recall
Marketed Without an Approved NDA/ANDA: Undeclared sibutramine and phenolphthalein in Burn 7 dietary supplement
Recall record
- Recall number
D-1351-2014- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Puerto Rico only
- Recall initiated
- 2013-12-23
- Classified by FDA Center
- 2014-05-27
- FDA published
- 2014-06-04
- Terminated
- 2017-05-03
- Recalling firm
- Deseo Rebajar
- Firm location
- Fajardo, PR