eXtenZone capsules, 1 capsule per blister pack, Distributed by: P.M.C. Company, Buena Park, CA 90621, UPC 6 89076 49126 6.

FDA recall notice · announced February 5, 2014 · Ss Wholesale Inc. Dba Jobbers Wholesale

Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.

The product

eXtenZone capsules, 1 capsule per blister pack, Distributed by: P.M.C. Company, Buena Park, CA 90621, UPC 6 89076 49126 6.

Reason for recall

Marketed Without An Approved NDA/ANDA: FDA analysis found eXtenZone 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 b

Notes

Distribution: CA
Lot/code information: Lot #: KWAKPMC03050517, Exp 12/16
Quantity: 2,395 blister packs total for all products
Status: Terminated
Products in this recall event:
- MaXtremeZEN capsules, 1 capsule per blister pack, Distributed by: P&A Enterprise, Buena Park, CA 90621, UPC 6 10079 52468 2. (D-1046-2014)
- Rhino 5 capsules(Spanish & English Labeling), 1 capsule per blister pack, Distributed by P&A Enterprise, Buena Park, CA 90621, English UPC 6 10708 10730 9, Spanish UPC 6 10708 10729 3. (D-1045-2014)
- eXtenZone capsules, 1 capsule per blister pack, Distributed by: P.M.C. Company, Buena Park, CA 90621, UPC 6 89076 49126 6. (D-1047-2014)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.