Drug product
FIFTY SHADES 6000 capsule, Proprietary Raw Material 4550, 1-capsule packets, distributed by Express Pac Trading, UPC 4026666146056
D-0105-2018
Product summary
- Event
- Event 78151
- Status
- Terminated
- Classification
- Class I
- Quantity
- 273 1-capsule packets
- Official record key
drug-enforcement:D-0105-2018
Official wording
Reason: Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil.
Code information: All Lots
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.