Drug product
5K Premium Enhancement capsule, 5000 mg, 1 count blister card, box of 30, Happy Together Inc., Boynton, FL UPC 649964965644
D-0388-2019
Product summary
- Event
- Event 81913
- Status
- Terminated
- Classification
- Class I
- Quantity
- N/A
- Official record key
drug-enforcement:D-0388-2019
Official wording
Reason: Marketed without an Approved NDA/ANDA; FDA analysis found product to be tainted with undeclared sildenafil and tadalafil
Code information: All lots within expiry
Distribution pattern: Product was sold over the internet
Derived failure modes
-
Unknown
Marketed without an Approved NDA/ANDA; FDA analysis found product to be tainted with undeclared sildenafil and tadalafil