FDA recall D-0959-2016

Reesna, Inc · Class I · drug

Product

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.

Distribution

Nationwide and United Kingdom

Key facts

Status: Terminated
Initiation date: 2015-12-11
Report date: 2016-06-15
Termination date: 2016-06-09
Voluntary/Mandated: Voluntary: Firm initiated
Location: Canoga Park, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0959-2016