FDA Recall D-1335-2014

Schindele Enterprises dba Midwest Wholesale · Nixa, MO

Class I — life-threatening Terminated 390 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.

Product

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

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

Quantity: 500 1-ct blisters; 30 3-ct bottles, 4 12-ct bottles

Reason for recall

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

Recall record

Recall number: D-1335-2014
Classification: Class I
Status: Terminated
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Press Release
Distribution: Distributed to PA, IL, TX, IA, GA, CT, FL, CA, LA, NY, MD, NV, and WI
Recall initiated: 2014-01-09
Classified by FDA Center: 2014-05-20
FDA published: 2014-05-28
Terminated: 2015-02-03
Recalling firm: Schindele Enterprises dba Midwest Wholesale
Firm location: Nixa, MO

‹ All recalls