Drug product
Panther Platinum 30000 Capsules, in green, black background with white, red text in hologram paper packaging, packaged in 2, 4, and 10 count blister cards, Motto International, Dallas, TX
D-0657-2020
Product summary
- Event
- Event 84526
- Status
- Terminated
- Classification
- Class I
- Quantity
- 1 box
- Official record key
drug-enforcement:D-0657-2020
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