October 2019 FDA Recall Drug by Green Lumber Holdings, Llc
D-0351-2020 - Marketed without an Approved NDA/ANDA

This Class I drug recall was voluntarily initiated by Green Lumber Holdings, Llc on October 22, 2019 for the product Drug. The FDA reported the reason for recall as marketed without an approved nda/anda. The product was distributed in United States and Canada. Only email addresses were provided, no physical address information was received. and the recall is currently terminated.

Recall Number: D-0351-2020

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.
Initiated
10-22-2019
Reported
11-13-2019
Quantity
approx. 30,000 capsules

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84105
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Green Lumber Holdings, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States and Canada. Only email addresses were provided, no physical address information was received.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-22-2023
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

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