5K Premium Enhancement capsule, 5000 mg, 1 count blister card, box of 30, Happy Together Inc., Boynton, FL UPC 649964965644
FDA recall notice · announced January 30, 2019 · Happy Together
Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.
The product
5K Premium Enhancement capsule, 5000 mg, 1 count blister card, box of 30, Happy Together Inc., Boynton, FL UPC 649964965644
Reason for recall
Marketed without an Approved NDA/ANDA; FDA analysis found product to be tainted with undeclared sildenafil and tadalafil
Notes
Distribution: Product was sold over the internet
Lot/code information: All lots within expiry
Quantity: N/A
Status: Terminated
Products in this recall event:
- 5K Premium Enhancement capsule, 5000 mg, 1 count blister card, box of 30, Happy Together Inc., Boynton, FL UPC 649964965644 (D-0388-2019)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.