PlainRecalls
FDA Drug Critical Class I Terminated

XZONE GOLD, 1 capsule blister 750 mg, Distributed by: XZONE, Orlando, FL.

Reported: May 28, 2014 Initiated: January 9, 2014 #D-1334-2014

Product Description

XZONE GOLD, 1 capsule blister 750 mg, Distributed by: XZONE, Orlando, FL.

Reason for Recall

Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil.

Details

Units Affected
175 blister packs
Distribution
Distributed to PA, IL, TX, IA, GA, CT, FL, CA, LA, NY, MD, NV, and WI
Location
Nixa, MO

Frequently Asked Questions

What product was recalled?
XZONE GOLD, 1 capsule blister 750 mg, Distributed by: XZONE, Orlando, FL.. Recalled by Schindele Enterprises dba Midwest Wholesale. Units affected: 175 blister packs.
Why was this product recalled?
Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil.
Which agency issued this recall?
This recall was issued by the FDA Drug on May 28, 2014. Severity: Critical. Recall number: D-1334-2014.