drugs Class I Updated 2014-02-05

SS Wholesale Inc. dba Jobbers Wholesale recalls MaXtremeZEN capsules, 1 capsule per blister pack, Distribute

Recalled Product

MaXtremeZEN capsules, 1 capsule per blister pack, Distributed by: P&A Enterprise, Buena Park, CA 90621, UPC 6 10079 52468 2.

Hazard / Issue

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

Issued by

FDA

Affected States: CA
Lot/Code Info: Lot #: JBP-L-1270-70, Exp 12/16
View official government recall

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