D-1335-2014 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
500 1-ct blisters; 30 3-ct bottles, 4 12-ct bottles

Product Description

BOOST ULTRA, sexual enhancement dietary supplement, 12-capsule/bottle. Also packaged in 3 pill bottles and 1 pill packs. BoostUtra.com, Springfield, MO.

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

12 pill bottle and 3 pill bottle: Lot # B70130 Exp. 03/15; 1 pill pack: Lot # 06012011 Exp 06/14.