eXtenZone capsules recalled for containing unapproved drug ingredients
SS Wholesale Inc. is recalling eXtenZone 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 eXtenZone capsules, 1 capsule per blister pack, distributed by P.M.C. Company 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 by the FDA for this use.
The recall involves 2,395 blister packs total for all products, with a distribution pattern limited to California. The specific lot number is KWAKPMC03050517 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
- eXtenZone capsules, 1 capsule per blister pack, Distributed by: P.M.C. Company, Buena Park, CA 90621, UPC 6 89076 49126 6.
- 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 #: KWAKPMC03050517
- 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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