FDA recall D-0388-2019

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

Distribution

Product was sold over the internet

Key facts

Status

Terminated

Initiation date

2019-01-08

Report date

2019-01-30

Termination date

2021-10-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

Boynton Beach, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0388-2019