Why it was recalled
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.
Product description
Poseidon Platinum 3500 capsule, 1-count per blister card, Distributed by: Poseidon, Made in the USA, UPC 0 95842 05876 0
Lot numbers, UPCs & expiration codes
All lots distributed 07/01/2019 through 09/28/2020.
Where it was sold
Unknown; unable to determine due to firm's Ebay account being closed.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0654-2021
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- May 11, 2021
- FDA report date
- Jul 21, 2021
- Quantity
- 36 capsules
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Yamtun7
Original FDA data
Every field from FDA enforcement report D-0654-2021, exactly as published.
Show all FDA fields
- City
- Delray Beach
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 87918
- Address
- 955 Egret Cir
- Code information
- All lots distributed 07/01/2019 through 09/28/2020.
- Postal code
- 33444-7603
- Report date
- Jul 21, 2021
- Product type
- Drugs
- Recall number
- D-0654-2021
- Classification
- Class I
- Recalling firm
- Yamtun7
- Product quantity
- 36 capsules
- Termination date
- Jul 12, 2023
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Poseidon Platinum 3500 capsule, 1-count per blister card, Distributed by: Poseidon, Made in the USA, UPC 0 95842 05876 0
- Distribution pattern
- Unknown; unable to determine due to firm's Ebay account being closed.
- Recall initiation date
- May 11, 2021
- Initial firm notification
- Press Release
- Center classification date
- Jul 12, 2021