The Recall Desk

FDA (Drugs) recall action 66406

Haute Health, LLC recalled 3 products on 2014-04-23

The FDA (Drugs) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2014-04-23
Critical
2
Units
428,544

Why these products were recalled

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.

Marketed without an Approved NDA/ANDA: Dietary supplement may contain amounts of an active ingredient found in some FDA-approved drugs for erectile dysfunction (ED) making the dietary supplement an unapproved drug.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–3 of 3

  • CriticalFDA (Drugs)··2014-04-23

    PHUK Sexual Enhancement Supplement Recalled for Unapproved Active Ingredients

    Haute Health, LLC is recalling PHUK Sexual Enhancement Ultimate Pleasure because it may contain unapproved active ingredients found in FDA-approved erectile dysfunction drugs.

    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.
    Category
    Distribution
    0 states
  • CriticalFDA (Drugs)··2014-04-23

    FDA Recalls Virilis Pro Dietary Supplement for Unapproved Drug Ingredients

    Haute Health is recalling Virilis Pro dietary supplements because they may contain unapproved active ingredients found in FDA-approved erectile dysfunction drugs.

    Product
    Virilis Pro, 450mg/capsule, Packaged in a 1 and 2 capsule blister packs and 10 capsule bottles, Manufactured for Haute Health Williamstown, NJ 08094 website: http://www.virilispro.com
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2014-04-23

    Prolifta Dietary Supplement Recalled for Unapproved Erectile Dysfunction Ingredients

    Haute Health, LLC is recalling Prolifta dietary supplements because they may contain unapproved active ingredients used in erectile dysfunction drugs.

    Product
    Prolifta Dietary Supplement Prolifta, 400mg/capsule, Packaged in 1 and 2 capsule blister packs and 4, 12, and 24 capsule bottles Made in the USA Distributed by: Prolifta LLC 1+877.239.8231 www.proliftaherbal.com.
    Category
    Distribution
    0 states