Drug product
Titanium 4000, capsule, 4000 mg, 1 count blister card, 30 blister display boxt, distributed by Titanium 4000 UPC 86077000020
D-1292-2019
Product summary
- Event
- Event 82758
- Status
- Terminated
- Classification
- Class I
- Quantity
- unknown
- Official record key
drug-enforcement:D-1292-2019
Official wording
Reason: Marketed without an approved NDA/ANDA: undeclared sildenafil and tadalafil.
Code information: Expiration 12/29/2020
Distribution pattern: Nationwide.
Derived failure modes
-
Unknown
Marketed without an approved NDA/ANDA: undeclared sildenafil and tadalafil.