eXtenZone capsules, 1 capsule per blister pack, Distributed by: P.M.C. Company, Buena Park, CA 9...
FDA Recall #D-1047-2014 — Class I — November 18, 2013
Product Description
eXtenZone capsules, 1 capsule per blister pack, Distributed by: P.M.C. Company, Buena Park, CA 90621, UPC 6 89076 49126 6.
Reason for Recall
Marketed Without An Approved NDA/ANDA: FDA analysis found eXtenZone 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 b
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 #: KWAKPMC03050517, Exp 12/16
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated