Drug product
BOOST ULTRA, sexual enhancement dietary supplement, 12-capsule/bottle. Also packaged in 3 pill bottles and 1 pill packs. BoostUtra.com, Springfield, MO.
D-1335-2014
Product summary
- Event
- Event 67228
- Status
- Terminated
- Classification
- Class I
- Quantity
- 500 1-ct blisters; 30 3-ct bottles, 4 12-ct bottles
- Official record key
drug-enforcement:D-1335-2014
Official wording
Reason: Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil.
Code information: 12 pill bottle and 3 pill bottle: Lot # B70130 Exp. 03/15; 1 pill pack: Lot # 06012011 Exp 06/14.
Distribution pattern: Distributed to PA, IL, TX, IA, GA, CT, FL, CA, LA, NY, MD, NV, and WI
Derived failure modes
-
Unknown
Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil.