D-1334-2014 Class I Terminated

Recalled by Schindele Enterprises dba Midwest Wholesale — Nixa, MO

Recall Details

Product Type
Drugs
Report Date
May 28, 2014
Initiation Date
January 9, 2014
Termination Date
February 3, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
175 blister packs

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.

Distribution Pattern

Distributed to PA, IL, TX, IA, GA, CT, FL, CA, LA, NY, MD, NV, and WI

Code Information

Lot # 130710GL, Exp. 07/31/2018