WOW, Health Enterprises, Dietary Supplement, 30 Caplets, Distributed by: Health Enterprises, 1...
FDA Recall #D-267-2013 — Class I — December 10, 2012
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.
Recalling Firm
Brower Enterprises Inc — Canton, SD
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
17,555 Bottles
Distribution
Nationwide and Puerto Rico (through the internet).
Code Information
All Lots
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated