FDA-Drug2014-02-05Class I
MaXtremeZEN capsules, 1 capsule per blister pack, Distributed by: P&A Enterprise, Buena Park, CA 90621, UPC 6 10079 52468 2.
SS Wholesale Inc. dba Jobbers Wholesale
Hazard
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
Sold states
CA
Affected count
2,395 blister packs total for all products
Manufactured in
16101 Garfield Ave, Paramount, CA, United States
Products
MaXtremeZEN capsules, 1 capsule per blister pack, Distributed by: P&A Enterprise, Buena Park, CA 90621, UPC 6 10079 52468 2.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1046-2014Don't want to check this manually?
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