FDA Recall D-1236-2014
Haute Health, LLC · Williamstown, NJ
Class I — life-threatening Terminated 489 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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.
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.
Recall record
- Recall number
D-1236-2014- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Nationwide and internationally via internet sales.
- Recall initiated
- 2013-09-27
- Classified by FDA Center
- 2014-04-15
- FDA published
- 2014-04-23
- Terminated
- 2015-01-29
- Recalling firm
- Haute Health, LLC
- Firm location
- Williamstown, NJ