Drug product
Poseidon Platinum 3500 capsule, 1-count per blister card, Distributed by: Poseidon, Made in the USA, UPC 0 95842 05876 0
D-0654-2021
Product summary
- Firm
- Yamtun7
- Event
- Event 87918
- Status
- Terminated
- Classification
- Class I
- Quantity
- 36 capsules
- Official record key
drug-enforcement:D-0654-2021
Official wording
Reason: 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.
Code information: All lots distributed 07/01/2019 through 09/28/2020.
Distribution pattern: Unknown; unable to determine due to firm's Ebay account being closed.
Derived failure modes
-
Unknown
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.