Drug 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.
D-1236-2014
Product summary
- Event
- Event 66406
- Status
- Terminated
- Classification
- Class I
- Quantity
- 172,800 capsules
- Official record key
drug-enforcement:D-1236-2014
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
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.