FDA recall D-0351-2020

Product

Green Lumber Natural Fuel For Men capsule, packaged in packs of 2, 4 and 10 capsules, 2618 San Miguel Drive, Suite #296, Newport Beach, CA 92660 (949) 426-8622.

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

United States and Canada. Only email addresses were provided, no physical address information was received.

Key facts

Status

Terminated

Initiation date

2019-10-22

Report date

2019-11-13

Termination date

2023-03-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Corona Del Mar, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0351-2020