FUEL UP PLUS, capsules, a) 1-count package, b) 5-count bottle, c) 10-count bottle WWW.FUELUPPILL...
FDA Recall #D-0959-2016 — Class I — December 11, 2015
Product Description
FUEL UP PLUS, capsules, a) 1-count package, b) 5-count bottle, c) 10-count bottle WWW.FUELUPPILLS.COM
Reason for Recall
Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplement: Products were found to be tainted with undeclared hydroxythiohomosildenafil, an analogue of Sildenafil, an FDA-approved drug for the treatment of male Erectile Dysfunction (ED), making them unapproved new drugs.
Recalling Firm
Reesna, Inc — Canoga Park, CA
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
26,250 capsules
Distribution
Nationwide and United Kingdom
Code Information
Exp. 12/18
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated