Drug product
XZONE GOLD, 1 capsule blister 750 mg, Distributed by: XZONE, Orlando, FL.
D-1334-2014
Product summary
- Event
- Event 67228
- Status
- Terminated
- Classification
- Class I
- Quantity
- 175 blister packs
- Official record key
drug-enforcement:D-1334-2014
Official wording
Reason: Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil.
Code information: Lot # 130710GL, Exp. 07/31/2018
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.