D-1237-2014 Class I Terminated
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
- 82,944 capsules
Product Description
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
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.