FDA recall D-1080-2020

Y-O Management LLC, dba Natural Remedy Store · Class I · 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

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

Distribution

Distributed in GA and TX

Key facts

Status: Terminated
Initiation date: 2020-03-16
Report date: 2020-04-08
Termination date: 2021-11-10
Voluntary/Mandated: Voluntary: Firm initiated
Location: San Antonio, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1080-2020