FDA Recall D-1334-2014
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
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.
Recall record
- Recall number
D-1334-2014- 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