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U.S. Department of Health and Human Services

Enforcement Report - Week of May 1, 2013

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Product Detail

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.
Recall Number D-267-2013
Classification Class I
Code Info All Lots
Product Distributed Qty 17,555 Bottles
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.

Event Detail

Event Id 63867
Product Type Drugs
Status Ongoing
Recalling Firm Brower Enterprises Inc
City Canton
State SD
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-12-10
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide and Puerto Rico (through the internet).
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