D-0654-2021 Class I Terminated
FDA drug recall D-0654-2021 was initiated by Yamtun7 on May 11, 2021 and is designated Class I. 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 therefo… The recall status is terminated (terminated July 12, 2023). Affected quantity: 36 capsules.
Recall Details
- Product Type
- Drugs
- Report Date
- July 21, 2021
- Initiation Date
- May 11, 2021
- Termination Date
- July 12, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 36 capsules
Product Description
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 Pattern
Unknown; unable to determine due to firm's Ebay account being closed.
Code Information
All lots distributed 07/01/2019 through 09/28/2020.