FDA Recall D-0223-2017
Love My Tru Body · McDonough, GA
Class I — life-threatening Terminated 160 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
Skinny Bee Diet capsules, 500 mg, packaged in a 60-count bottle
Reason for recall
Marketed without an approved NDA/ANDA: presence of undeclared sibutramine, desmethylsibutramine (an active metabolite of sibutramine) and phenolphthalein.
Recall record
- Recall number
D-0223-2017- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide
- Recall initiated
- 2016-10-28
- Classified by FDA Center
- 2016-12-22
- FDA published
- 2016-12-28
- Terminated
- 2017-04-06
- Recalling firm
- Love My Tru Body
- Firm location
- McDonough, GA