Elevated risk U.S. Food and Drug Administration

Green Lumber Dietary supplements for male sexual enhancement recall: Contains Tadalafil

Recall published 7+ years ago

Contains Tadalafil

Green Lumber Prescription & OTC drugs — recalled prescription & otc drugsGreen Lumber Prescription & OTC drugs — recalled prescription & otc drugs (photo 2)Green Lumber Prescription & OTC drugs — recalled prescription & otc drugs (photo 3)
3 photos published by U.S. Food and Drug Administration with the recall notice.

The hazard: Undeclared allergen or ingredient

The food itself is fine. What is wrong is the label, and for the households that rely on that label it is a real risk.

What the notice says: Consumption of a product with undeclared tadalafil may pose a risk to consumers who take prescription medications containing nitrates (such as nitroglycerin).

Why it matters: An ingredient that U.S. law requires to be declared is present but missing from the label. People who avoid that ingredient cannot make a safe choice from the packaging.

Symptoms and when to call a doctor

An undeclared allergen is a danger only to people allergic or intolerant to that ingredient. For everyone else the food is safe. Reactions range from an itchy mouth, hives, stomach cramps or vomiting through to anaphylaxis — swelling of the lips, tongue or throat, a tight chest, wheezing, a sudden drop in blood pressure or collapse. If anaphylaxis is suspected, use an epinephrine auto-injector straight away and call 911, even if the symptoms seem to settle, because a second wave can follow hours later.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Published
October 22, 2019
Risk level
Elevated risk
Issued by
U.S. Food and Drug Administration
Brand
Green Lumber
Product type
Prescription & OTC drugs

Products covered by this recall

Dietary supplements for male sexual enhancement

What the company announced

FOR IMMEDIATE RELEASE – Newport Beach, California. GL Holdings is voluntarily recalling six lots of Green Lumber 2-, 4-, and 10-capsule packages purchased on or before August 10, 2019 to the consumer level. FDA analysis has found one lot of Green Lumber distributed between June and August 2019 to be tainted with tadalafil.

Consumption of a product with undeclared tadalafil may pose a risk to consumers who take prescription medications containing nitrates (such as nitroglycerin). The combination of tadalafil and nitrates may lower blood pressure to dangerous levels which can be life threatening. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates and may be the population most likely to be affected. To date, GL Holdings has not received any reports of adverse events related to this recall.

GL Holdings is recalling the lot that tested positive for tadalafil and, out of an abundance of caution, GL Holdings is also recalling all previous lots, thus this recall encompasses all Green Lumber products sold on or before August 10, 2019. Tadalafil is an FDA approved drug for the treatment of erectile dysfunction. The presence of tadalafil in the Green Lumber products renders them unapproved drugs for which safety and efficacy have not been established, and therefor subject to recall.

The Green Lumber product is marketed as dietary supplements for male sexual enhancement and is packaged in 2-, 4-, and 10-capsule blister packs.

The Green Lumber lot that tested positive for tadalafil was sold between June 10 and August 10, 2019. Some of the blister packs are marked with “XC06 EXP 06/2022.” It is sold in a white wrapper with a green Green Lumber logo on the front and has one of the following UPC codes:

2 pack: X0020TSV4R

4 pack: X0020TRRHJ

10 Pack: X0020TUJLZ

Other lots that are being recalled were sold between April 1, 2018 and June 10, 2019 and may have a different UPC code on the package. Some of these blister packages are marked with one of the following “XC12EXP12/2020,” “XC06EXP06/2021,” “XC10EXP10/2021,” “XC02EXP02/2022,” or “XC04EXP04/2022.”

Images of these packages are included below so that they may be more easily identified by consumers.

This product was distributed in the United States and Canada via internet sales.

GL Holdings is notifying its distributors and customers by email and is arranging for replacement of recalled products, at the request of the customer. Consumers with questions regarding this recall can contact GL Holdings via email at [email protected] at any time or by phone at 949-426-8622 on Monday through Friday between the hours of 9 a.m. to 5 p.m. Pacific Time.

Consumers who purchased the product should stop consuming it and return any unused product to GL Holdings. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report Online : www.fda.gov/medwatch/report.htm

Regular Mail or Fax : Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.

Check your product

The notice names 5 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • 06/2022

Model or item number

On the rating label, the box or the instruction sheet.

  • August 10, 2019

Package size

Match the net weight or the piece count on the front of the pack.

  • 2 pack
  • 4 pack
  • 10 Pack

Codes are lifted verbatim from the FDA — Company recall announcements notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Allergen

Green Lumber — The food itself is fine. What is wrong is the label, and for the households that rely on that label it is a real risk.

  1. Read the official notice above for the exact ingredient involved, then check whether anyone in your home avoids it.
  2. If someone does avoid it, stop serving it and check anything already cooked with it.
  3. Warn anyone else who eats from your kitchen, including schools and childminders.
  4. Report any reaction to the FDA so it is recorded against this recall.

Getting a refund without the pack

The commonest reason people skip the refund is that they have already thrown the item away. That rarely matters.

  • A photo of the label and lot code is accepted by most grocers, and so is a card statement line showing the purchase.
  • Store credit is often offered first. You can ask for the original payment method instead, and it is normally granted.
  • No photo either? Ask anyway. Grocery chains settle recall refunds at the service desk because disputing them costs more than paying them.
  • For a multi-pack or a case, ask for the full purchase price rather than a per-unit figure — the recall covers what you paid.

Remedy named in the notice: GL Holdings is notifying its distributors and customers by email and is arranging for replacement of recalled products, at the request of the customer.

Company contact: GL Holdings — Consumers: GL Holdings, (949) 426-8622, [email protected]

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Company recall announcements record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Green Lumber prescription & otc drugs recalled?

Contains Tadalafil Consumption of a product with undeclared tadalafil may pose a risk to consumers who take prescription medications containing nitrates (such as nitroglycerin).

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: best-by date 06/2022; model number August 10, 2019. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Read the official notice above for the exact ingredient involved, then check whether anyone in your home avoids it.

Can I get my money back?

The notice says: GL Holdings is notifying its distributors and customers by email and is arranging for replacement of recalled products, at the request of the customer.

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