Drug product
XZEN PLATINUM, 750 mg, Distributed by: XZEN, Los Angeles, CA.
D-1340-2014
Product summary
- Event
- Event 67228
- Status
- Terminated
- Classification
- Class I
- Quantity
- 89 blister packs
- Official record key
drug-enforcement:D-1340-2014
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 130520PL Exp. 05/31/2017
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.