April 2014 FDA Recall Drug by Nature's Universe
D-1594-2014 - Marketed Without an Approved NDA/ANDA

This Class I drug recall was voluntarily initiated by Nature's Universe on April 9, 2014 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-1594-2014

Reason for Recall
Marketed Without an Approved NDA/ANDA: Product contains undeclared sibutramine.
Initiated
04-09-2014
Reported
09-24-2014
Quantity
Unknown

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
68455
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.
Nature's Universe
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide and Canada
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-10-2015
Product Description About Product Description
Full technical description of the product.
THINOGENICS, WEIGHT LOSS MADE EASY! DIETARY SUPPLEMENT, 30 CAPSULES, 30 Count Bottles, THINOGENICS LLC, Nashville, TN 37203 USA.

Batch or Lot Expiration Information

Lot# None Available. All lots distributed prior to 02/06/2014 are being recalled.