Home / Recalls / Haute Health, LLC / D-1236-2014

D-1236-2014 Class I Terminated

Recalled by Haute Health, LLC — Williamstown, NJ

Recall Details

Product Type: Drugs
Report Date: April 23, 2014
Initiation Date: September 27, 2013
Termination Date: January 29, 2015
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 172,800 capsules

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.

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.

Distribution Pattern

Nationwide and internationally via internet sales.

Code Information

All lot codes and expiration dates.