March 2020 FDA Recall Drug by Y-o Management Llc, Dba Natural Remedy Store
D-1080-2020 - Marketed without an Approved NDA/ANDA

This Class I drug recall was voluntarily initiated by Y-o Management Llc, Dba Natural Remedy Store on March 16, 2020 for the product Drug. The FDA reported the reason for recall as marketed without an approved nda/anda. The product was distributed in Distributed in GA and TX and the recall is currently terminated.

Recall Number: D-1080-2020

Reason for Recall
Marketed without an Approved NDA/ANDA: FDA analysis found this product to contain undeclared Tadalafil, an FDA approved drug for the treatment of erectile dysfunction
Initiated
03-16-2020
Reported
04-08-2020
Quantity
19156 packets estimated distributed

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85232
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.
Y-O Management LLC, dba Natural Remedy Store
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.
Distributed in GA and TX
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-10-2021
Product Description About Product Description
Full technical description of the product.
Natural Remedies Active Male 500 mg Male Pleasure Formula Dietary Supplement Manufactured For: Natural Remedies San Antonio, TX, USA 1(877)543-3501

Batch or Lot Expiration Information

Lot# All lots remaining within expiry.