Drug product

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

D-1080-2020

March 16, 2020

Class I

Product summary

Firm: Y-O Management LLC, dba Natural Remedy Store
Event: Event 85232
Status: Terminated
Classification: Class I
Quantity: 19156 packets estimated distributed
Official record key: drug-enforcement:D-1080-2020

Official wording

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

Code information: All lots remaining within expiry.

Distribution pattern: Distributed in GA and TX

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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