FDA recall D-0654-2021

Yamtun7 · Class I · drug

Product

Poseidon Platinum 3500 capsule, 1-count per blister card, Distributed by: Poseidon, Made in the USA, UPC 0 95842 05876 0

Reason for recall

Marketed Without An Approved NDA/ANDA: Product found to contain undeclared sildenafil and tadalafil making them unapproved drugs for which the safety and efficacy have not been established and therefore subject to recall.

Distribution

Unknown; unable to determine due to firm's Ebay account being closed.

Key facts

Status
Terminated
Initiation date
2021-05-11
Report date
2021-07-21
Termination date
2023-07-12
Voluntary/Mandated
Voluntary: Firm initiated
Location
Delray Beach, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0654-2021