Drug product
Spanish Fly 22K capsules, 2-count box, UPC 0 664979 979455
D-0448-2024
Product summary
- Event
- Event 94265
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 45 boxes
- Official record key
drug-enforcement:D-0448-2024
Official wording
Reason: Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Code information: All lots
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Unknown
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.