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Recall Observatory FDA recall evidence

Drug 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

D-1237-2014

September 27, 2013

Class I

Product summary

Firm
Haute Health, LLC
Event
Event 66406
Status
Terminated
Classification
Class I
Quantity
82,944 capsules
Official record key
drug-enforcement:D-1237-2014

Official wording

Reason: 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.

Code information: All lot codes and expiration dates.

Distribution pattern: Nationwide and internationally via internet sales.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.