September 2015 FDA Recall Drug by Fit Firm And Fabulous
D-0722-2016 - Marketed Without An Approved NDA/ANDA

This Class I drug recall was voluntarily initiated by Fit Firm And Fabulous on September 29, 2015 for the product Drug. The FDA reported the reason for recall as marketed without an approved nda/anda. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0722-2016

Reason for Recall
Marketed Without An Approved NDA/ANDA: product marketed as a dietary supplement was found to be tainted with undeclared sibutramine, a previously approved controlled substance that was removed from the U.S. market in October 2010 for safety reasons, in this tainted product renders it an unapproved drug.
Initiated
09-29-2015
Reported
02-24-2016
Quantity
3000 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72874
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.
Fit Firm and Fabulous
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.
Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the U.S.A. via the website.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-16-2016
Product Description About Product Description
Full technical description of the product.
Ultimate Herbal Slimcap Capsules, 350 mg*, 30-count bottles, labeled Part 1 of 3, fit firm & fabulous, UPC 5 42423 25422 1.

Batch or Lot Expiration Information

Lot# : 05/02/2015 to 05/01/2017