Green Lumber Natural Fuel For Men capsules recalled for undeclared Tadalafil
Green Lumber Holdings is recalling Natural Fuel For Men capsules because FDA analysis found undeclared Tadalafil, an approved drug for erectile dysfunction.
The agency’s classification
FDA (Drugs): Class I
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.
Plain-English summary
Green Lumber Holdings, LLC is recalling approximately 30,000 capsules of Green Lumber Natural Fuel For Men. The product is packaged in packs of 2, 4, and 10 capsules. The recall covers specific lots with expiration dates ranging from December 2020 to June 2022.
The FDA initiated this recall because analysis found the product contains undeclared Tadalafil, an FDA-approved drug used to treat erectile dysfunction. The product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). The affected units were distributed in the United States and Canada.
Consumers who have purchased this product should stop using it and contact the recalling firm for instructions on how to return the product or obtain a refund.
The recalled product
- 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.
- Manufacturer
- Green Lumber Holdings, LLC
- Category
- Drug — Dietary Supplement
- Hazard
- Affected units
- 30,000
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (11)
- Lot #: XC12
- EXP 12/2020
- XC06
- EXP06/2021
- XC10
- EXP 10/2021
- XC02
- EXP 02/2022
- XC04
- EXP 04/2022
- EXP06/2022
Distribution
Distribution scope not specified by the agency.
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