D-1046-2014 Class I Terminated
FDA drug recall D-1046-2014 was initiated by SS Wholesale Inc. dba Jobbers Wholesale on November 18, 2013 and is designated Class I. Reason for recall: 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 i… The recall status is terminated (terminated May 9, 2014). Affected quantity: 2,395 blister packs total for all products.
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
MaXtremeZEN capsules, 1 capsule per blister pack, Distributed by: P&A Enterprise, Buena Park, CA 90621, UPC 6 10079 52468 2.
Reason for Recall
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
Distribution Pattern
CA
Code Information
Lot #: JBP-L-1270-70, Exp 12/16