Drug 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.

D-0351-2020

October 22, 2019

Class I

Product summary

Firm: Green Lumber Holdings, LLC
Event: Event 84105
Status: Terminated
Classification: Class I
Quantity: approx. 30,000 capsules
Official record key: drug-enforcement:D-0351-2020

Official wording

Reason: 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.

Code information: Lot #: XC12, EXP 12/2020; XC06, EXP06/2021; XC10, EXP 10/2021; XC02, EXP 02/2022; XC04, EXP 04/2022; XC06, EXP06/2022

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

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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.