D-1335-2014 Class I Terminated
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.