Drug product
PapaZen 3300 capsule, Proprietary Blend 1800mg, 1-capsule packets, distributed by FX Power San Diego, CA 92108, UPC 718122032587
D-0104-2018
Product summary
- Event
- Event 78151
- Status
- Terminated
- Classification
- Class I
- Quantity
- 89 1-capsule packets
- Official record key
drug-enforcement:D-0104-2018
Official wording
Reason: Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil.
Code information: Lot# NSS050888, EXP 05-2018
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Unknown
Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil.