Why it was recalled
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.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot #: XC12, EXP 12/2020; XC06, EXP06/2021; XC10, EXP 10/2021; XC02, EXP 02/2022; XC04, EXP 04/2022; XC06, EXP06/2022
Where it was sold
United States and Canada. Only email addresses were provided, no physical address information was received.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0351-2020
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Oct 22, 2019
- FDA report date
- Nov 13, 2019
- Quantity
- approx. 30,000 capsules
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Green Lumber Holdings, LLC
Original FDA data
Every field from FDA enforcement report D-0351-2020, exactly as published.
Show all FDA fields
- City
- Corona Del Mar
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 84105
- Address
- 2855 E Coast Hwy Ste 228
- 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
- Postal code
- 92625-2200
- Report date
- Nov 13, 2019
- Product type
- Drugs
- Recall number
- D-0351-2020
- Classification
- Class I
- Recalling firm
- Green Lumber Holdings, LLC
- Product quantity
- approx. 30,000 capsules
- Termination date
- Mar 22, 2023
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- United States and Canada. Only email addresses were provided, no physical address information was received.
- Recall initiation date
- Oct 22, 2019
- Initial firm notification
- Letter
- Center classification date
- Nov 15, 2019