Rhino 5 capsules(Spanish & English Labeling), 1 capsule per blister pack, Distributed by P&A Ente...
FDA Recall #D-1045-2014 — Class I — November 18, 2013
Product Description
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.
Reason for Recall
Marketed Without An Approved NDA/ANDA: FDA analysis found Rhino 5 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 by
Recalling Firm
SS Wholesale Inc. dba Jobbers Wholesale — Paramount, CA
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
2,395 blister packs total for all products
Distribution
CA
Code Information
Lot #: KWAKPMC030505175957019, Exp 12/16
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.