The Recall Desk
CriticalFDA (Drugs)·D-1046-2014·Announced 2014-02-05

MaXtremeZEN Capsules Recalled for Containing Unapproved Drug Ingredients

SS Wholesale Inc. is recalling MaXtremeZEN capsules because FDA analysis found undeclared desmethyl carbondenafil and dapoxetine, making the product an unapproved new drug.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.

Plain-English summary

SS Wholesale Inc. dba Jobbers Wholesale is recalling MaXtremeZEN capsules, 1 capsule per blister pack, distributed by P&A Enterprise in Buena Park, CA. The product is marketed as a dietary supplement but was found to contain undeclared desmethyl carbondenafil and dapoxetine.

FDA analysis determined that desmethyl carbondenafil is a phosphodiesterase (PDE)-5 inhibitor, a class of drugs used to treat male erectile dysfunction. The presence of this ingredient makes the product an unapproved new drug. Dapoxetine is also an active ingredient not approved for use in this context.

The recall involves 2,395 blister packs total for all products, with a distribution pattern limited to California. The specific lot number is JBP-L-1270-70 with an expiration date of 12/16. Consumers should stop using the product and contact the distributor or manufacturer for further instructions.

The recalled product

Product
MaXtremeZEN capsules, 1 capsule per blister pack, Distributed by: P&A Enterprise, Buena Park, CA 90621, UPC 6 10079 52468 2.
Manufacturer
SS Wholesale Inc. dba Jobbers Wholesale
Category
Drug — Dietary Supplement
Hazard
Affected units
2,395

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot #: JBP-L-1270-70
  • Exp 12/16

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 3 recalled by SS Wholesale Inc. dba Jobbers Wholesale under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

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