November 2015 FDA Recall Drug by Super Herbs (D-0909-2016 - Marketed without an approved NDA/ANDA - presence of undeclared sibutramine, desmethylsibutramine (an active metabolite of sibutramine) and/or phenolphthalein.)

This Class I drug recall was voluntarily initiated by Super Herbs on November 23, 2015 for the product Drug. The FDA reported the reason for recall as marketed without an approved nda/anda - presence of undeclared sibutramine, desmethylsibutramine (an active metabolite of sibutramine) and/or phenolphthalein.. The product was distributed in 9 consignees - only 9 bottles distributed and the recall is currently terminated.

Recall Number: D-0909-2016

Reason for Recall
Marketed without an approved NDA/ANDA - presence of undeclared sibutramine, desmethylsibutramine (an active metabolite of sibutramine) and/or phenolphthalein.
Initiated
11-23-2015
Reported
06-01-2016
Quantity
9 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73361
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Super Herbs
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
9 consignees - only 9 bottles distributed
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-01-2024
Product Description About Product Description
Full technical description of the product.
SUPER HERBS 350 mg, 30 capsules per bottle.

Batch or Lot Expiration Information

Lot# All lots