June 2013 FDA Recall Drug by Bethel Nutritional Consulting, Inc
D-921-2013 - Marketed Without An Approved NDA/ANDA

This Class I drug recall was voluntarily initiated by Bethel Nutritional Consulting, Inc on June 11, 2013 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-921-2013

Reason for Recall
Marketed Without An Approved NDA/ANDA: FDA analysis found this product contained undeclared sibutramine and phenolphthalein, two active ingredients that were once marketed in the U.S. but removed due to safety reasons, making this product an unapproved new drug.
Initiated
06-11-2013
Reported
09-04-2013
Quantity
18,678 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
65441
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.
Bethel Nutritional Consulting, Inc
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.
Nationwide. Product was also available for sale via internet
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-27-2018
Product Description About Product Description
Full technical description of the product.
Bethel 30 capsules, packaged in 30 count bottles, Distributed by BETHEL INC. New York, New York

Batch or Lot Expiration Information

Lot# : 120514, EXP: 12/2014