D-1047-2014 Class I Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- February 5, 2014
- Initiation Date
- November 18, 2013
- Termination Date
- May 9, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,395 blister packs total for all products
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
Distribution Pattern
CA
Code Information
Lot #: KWAKPMC03050517, Exp 12/16