March 2021 FDA Recall Drug by Antoto-k
D-0366-2021 - Marketed without Approved NDA/ANDA

This Class II drug recall was voluntarily initiated by Antoto-k on March 26, 2021 for the product Drug. The FDA reported the reason for recall as marketed without approved nda/anda. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0366-2021

Reason for Recall
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of sildenafil and tadalafil.
Initiated
03-26-2021
Reported
05-12-2021
Quantity
200 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87627
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Antoto-K
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.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-18-2022
Product Description About Product Description
Full technical description of the product.
Thumbs Up 7 Red 70K, 10 count blister pack cartons, Distributed by Ummzy LLC., Made in USA, UPC 6 17135 89467 3.

Batch or Lot Expiration Information

Lot# All lots within expiry.