FDA Recall D-0909-2016
Super Herbs · Miami, FL
Class I — life-threatening Terminated 3235 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
SUPER HERBS 350 mg, 30 capsules per bottle.
Reason for recall
Marketed without an approved NDA/ANDA - presence of undeclared sibutramine, desmethylsibutramine (an active metabolite of sibutramine) and/or phenolphthalein.
Recall record
- Recall number
D-0909-2016- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Distribution
- 9 consignees - only 9 bottles distributed
- Recall initiated
- 2015-11-23
- Classified by FDA Center
- 2016-05-26
- FDA published
- 2016-06-01
- Terminated
- 2024-10-01
- Recalling firm
- Super Herbs
- Firm location
- Miami, FL