PlainRecalls
FDA Drug Critical Class I Terminated

FUEL UP PLUS, capsules, a) 1-count package, b) 5-count bottle, c) 10-count bottle WWW.FUELUPPILLS.COM

Reported: June 15, 2016 Initiated: December 11, 2015 #D-0959-2016

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.

Details

Recalling Firm
Reesna, Inc
Units Affected
26,250 capsules
Distribution
Nationwide and United Kingdom
Location
Canoga Park, CA

Frequently Asked Questions

What product was recalled?
FUEL UP PLUS, capsules, a) 1-count package, b) 5-count bottle, c) 10-count bottle WWW.FUELUPPILLS.COM. Recalled by Reesna, Inc. Units affected: 26,250 capsules.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Drug on June 15, 2016. Severity: Critical. Recall number: D-0959-2016.