December 2012 FDA Recall Drug by Brower Enterprises Inc
D-267-2013 - Marketed without an Approved NDA/ANDA

This Class I drug recall was voluntarily initiated by Brower Enterprises Inc on December 10, 2012 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-267-2013

Reason for Recall
Marketed without an Approved NDA/ANDA: Brower Enterprises Inc., is recalling its WOW Health Enterprises Dietary Supplement, because it contains undeclared drug ingredients making it an unapproved drug. FDA sample analysis has found the product to contain methocarbamol, dexamethasone, and diclofenac.
Initiated
12-10-2012
Reported
05-01-2013
Quantity
17,555 Bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
63867
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.
Brower Enterprises 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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide and Puerto Rico (through the internet).
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-14-2013
Product Description About Product Description
Full technical description of the product.
WOW, Health Enterprises, Dietary Supplement, 30 Caplets, Distributed by: Health Enterprises, 1002 E 5th St., Canton, SD 57013. Manufactured by Riger Natural, S. A. Mexico.

Batch or Lot Expiration Information

Lot# All Lots