Haute Health, LLC recalls PHUK Sexual Enhancement Ultimate Pleasure, 400mg/capsule, packaged in 1 and 2 capsule blister packs and 4,12,24 capsule
Recalled April 23, 2014 · FDA recall D-1236-2014 · Haute Health
Hazard
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. · FDA Class I
Units
172,800 capsules
Sold at
Nationwide and internationally via internet sales.
Description
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.
Product
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.
Manufacturer(s)
Haute Health, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →