D-0909-2016 Class I Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- June 1, 2016
- Initiation Date
- November 23, 2015
- Termination Date
- October 1, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9 bottles
Product Description
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.
Distribution Pattern
9 consignees - only 9 bottles distributed
Code Information
All lots