Natural Remedies Active Male 500 mg Male Pleasure Formula Dietary Supplement Manufactured For: Natural…

Date

April 8, 2020

Risk class

Class I (FDA's definition, 21 CFR 7.3(m): 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)

Status

Terminated

Filed by

Y-O Management LLC, dba Natural Remedy Store

Product

Natural Remedies Active Male 500 mg Male Pleasure Formula Dietary Supplement Manufactured For: Natural Remedies San Antonio, TX, USA 1(877)543-3501

Reason

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

Distribution pattern

Distributed in GA and TX

Quantity

19156 packets estimated distributed

Codes and lots

All lots remaining within expiry.

Recall started

March 16, 2020

Recall number

D-1080-2020

What should I do? Medicine recall: what to do

Source: FDA · Drug enforcement report, recall number D-1080-2020. The agency record governs; check it and the company before acting.