FDAFDA · Food and drugs·Recall number D-1046-2014
MaXtremeZEN capsules, 1 capsule per blister pack, Distributed by: P&A Enterprise, Buena Park, CA 90621, UPC 6 10079 52468 2.
Published February 5, 2014 · Recall initiated: November 18, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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
What to do
Voluntary: Firm initiated · Press Release
Recall details
- Manufacturer
- SS Wholesale Inc. dba Jobbers Wholesale
- Distributor
- CA
- Lot
- Lot #: JBP-L-1270-70, Exp 12/16
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
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