Drug product
Stallion Platinum 30000 Capsules in blue,orange,white background with red,white text in hologram paper packaging, packaged in 2, 4, 10 count blister cards, Motto International, Dallas, TX
D-0655-2020
Product summary
- Event
- Event 84526
- Status
- Terminated
- Classification
- Class I
- Quantity
- 7 boxes
- Official record key
drug-enforcement:D-0655-2020
Official wording
Reason: Marketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil
Code information: All lots remaining within expiry.
Distribution pattern: TX
Derived failure modes
-
Unknown
Marketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil