MaXtremeZEN capsules, 1 capsule per blister pack, Distributed by: P&A Enterprise, Buena Park, CA ...
FDA Recall #D-1046-2014 — Class I — November 18, 2013
Product Description
MaXtremeZEN capsules, 1 capsule per blister pack, Distributed by: P&A Enterprise, Buena Park, CA 90621, UPC 6 10079 52468 2.
Reason for Recall
Marketed Without An Approved NDA/ANDA: FDA analysis found MaXtremeZEN which is marketed as a dietary supplement to contain undeclared desmethyl carbondenafil and dapoxetine. Desmethyl carbondenafil is a phosphodiesterase (PDE)-5 inhibitors which is a class of drugs used to treat male erectile dysfunction, making this product an unapproved new drug. Dapoxetine is an active ingredient not approved
Recalling Firm
SS Wholesale Inc. dba Jobbers Wholesale — Paramount, CA
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
2,395 blister packs total for all products
Distribution
CA
Code Information
Lot #: JBP-L-1270-70, Exp 12/16
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated