FDA recall D-0500-2019

Product

the silver bullet 10x Capsules, 725 mg each (proprietary blend of: Mucuna Pruriens Extract, Horny Goat Weed, Ginger Root Extract, Icariin, Wolf Berry (fruit) Lactase, Tribulus Terrestris Extract, Piperine), 10 count mylar package, Nature's Rx, Claremont, CA

Reason for recall

Marketed without an Approved NDA/ANDA; FDA analysis found product to be tainted with undeclared sildenafil and tadalafil

Distribution

eBay sales

Key facts

Status

Terminated

Initiation date

2019-01-25

Report date

2019-02-13

Termination date

2023-02-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Claremont, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0500-2019