FDA recall D-1047-2014

Product

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

CA

Key facts

Status

Terminated

Initiation date

2013-11-18

Report date

2014-02-05

Termination date

2014-05-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Paramount, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1047-2014