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.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. 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
- 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.
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