FDA recall D-0966-2017

Organic Herbal Supply · Class I · drug

Product

TORNADO Male Enhancement Herbal Dietary Supplement Capsules, Over 4000 mg value, supplied in 2, 4 and 10 count packages, Made in USA Distributed by American Health Supplements, Chicago, Illinois --- UPC Code 680474228959

Reason for recall

Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin

Distribution

Nationwide via internet

Key facts

Status
Terminated
Initiation date
2017-04-18
Report date
2017-07-19
Termination date
2018-03-09
Voluntary/Mandated
Voluntary: Firm initiated
Location
Roseville, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0966-2017