SUPER HERBS 350 mg, 30 capsules per bottle.
FDA Recall #D-0909-2016 — Class I — November 23, 2015
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.
Recalling Firm
Super Herbs — Miami, FL
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
9 bottles
Distribution
9 consignees - only 9 bottles distributed
Code Information
All lots
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated