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U.S. Department of Health and Human Services

Enforcement Report - Week of April 23, 2014

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Product Detail

Product Description PHUK Sexual Enhancement Ultimate Pleasure, 400mg/capsule, packaged in 1 and 2 capsule blister packs and 4,12,24 capsule bottles, Distributed by UME Supplements, INC www.phukherbal.com.
Recall Number D-1236-2014
Classification Class I
Code Info All lot codes and expiration dates.
Product Distributed Qty 172,800 capsules
Reason For Recall Marketed without an Approved NDA/ANDA: Dietary supplement may contain amounts of active ingredients found in some FDA-approved drugs for erectile dysfunction (ED) making the dietary supplement an unapproved drug.

Event Detail

Event Id 66406
Product Type Drugs
Status Ongoing
Recalling Firm Haute Health, LLC
City Williamstown
State NJ
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-09-27
Initial Firm Notification of Consignee or Public Press Release
Distribution Pattern Nationwide and internationally via internet sales.
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