FDA Recall D-0654-2021
Yamtun7 · Delray Beach, FL
Class I — life-threatening Terminated 792 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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.
Recall record
- Recall number
D-0654-2021- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Unknown; unable to determine due to firm's Ebay account being closed.
- Recall initiated
- 2021-05-11
- Classified by FDA Center
- 2021-07-12
- FDA published
- 2021-07-21
- Terminated
- 2023-07-12
- Recalling firm
- Yamtun7
- Firm location
- Delray Beach, FL