May 2021 FDA Recall Drug by Yamtun7
D-0654-2021 - Marketed Without An Approved NDA/ANDA

This Class I drug recall was voluntarily initiated by Yamtun7 on May 11, 2021 for the product Drug. The FDA reported the reason for recall as marketed without an approved nda/anda. The product was distributed in Unknown; unable to determine due to firm's Ebay account being closed. and the recall is currently terminated.

Recall Number: D-0654-2021

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.
Initiated
05-11-2021
Reported
07-21-2021
Quantity
36 capsules

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87918
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Yamtun7
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Unknown; unable to determine due to firm's Ebay account being closed.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-12-2023
Product Description About Product Description
Full technical description of the product.
Poseidon Platinum 3500 capsule, 1-count per blister card, Distributed by: Poseidon, Made in the USA, UPC 0 95842 05876 0

Batch or Lot Expiration Information

Lot# All lots distributed 07/01/2019 through 09/28/2020.