Drug product
Bull Platinum 30000 Capsules, 1000 mg, in orange, white, yellow background with silver text, packaged in 2, 4 and 10 count blister cards, Motto International, Dallas, TX
D-0654-2020
Product summary
- Event
- Event 84526
- Status
- Terminated
- Classification
- Class I
- Quantity
- 8 boxes
- Official record key
drug-enforcement:D-0654-2020
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