Home / Recalls / Brower Enterprises Inc / D-267-2013

D-267-2013 Class I Terminated

Recalled by Brower Enterprises Inc — Canton, SD

Recall Details

Product Type: Drugs
Report Date: May 1, 2013
Initiation Date: December 10, 2012
Termination Date: November 14, 2013
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 17,555 Bottles

Product Description

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.

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.

Distribution Pattern

Nationwide and Puerto Rico (through the internet).

Code Information

All Lots