FDA recall D-1236-2014

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.

Distribution

Nationwide and internationally via internet sales.

Key facts

Status

Terminated

Initiation date

2013-09-27

Report date

2014-04-23

Termination date

2015-01-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Williamstown, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1236-2014