FDA recall D-0964-2017

Product

Xrect Male Enhancement Herbal Dietary Supplement Capsules, 500 mg supplied in 2, 4 and 10 count packages, Distributed by Organic Herbal Supply, Roseville, CA ---- UPC Code 680474015795

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-0964-2017