Drug product
RHINO 7 Platinum 5000, capsule, Proprietary Material: 750mg, 1-capsule packets, distributed by Fifty Shades Bayside, NY 11361, UPC 617135861224
D-0103-2018
Product summary
- Event
- Event 78151
- Status
- Terminated
- Classification
- Class I
- Quantity
- 925 1-capsule packets
- Official record key
drug-enforcement:D-0103-2018
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.