Recall Enforment Report D-1237-2014
Recall Details
Multi event Drug Recall Enforcement Report Class I voluntary initiated by Haute Health, LLC, originally initiated on 09-27-2013 for the 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 The product was recalled due to 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.. The product was distributed nationwide and the recall is currently terminated.
Recall Enforcement Reports
| Recall Number | Recall Initiation Date | Report Date | Recall Classification | Quantity | Product Description | Recall Reason | Status |
|---|---|---|---|---|---|---|---|
| D-1237-2014 | 09-27-2013 | 04-23-2014 | Class I | 82,944 capsules | 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 | 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. | Terminated |
| D-1235-2014 | 09-27-2013 | 04-23-2014 | Class I | 172,800 capsules | 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. | 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. | Terminated |
| D-1236-2014 | 09-27-2013 | 04-23-2014 | Class I | 172,800 capsules | 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. | 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. | Terminated |
