Recalls / Class I
Class ID-0351-2020
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
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.
- Affected lot / code info
- Lot #: XC12, EXP 12/2020; XC06, EXP06/2021; XC10, EXP 10/2021; XC02, EXP 02/2022; XC04, EXP 04/2022; XC06, EXP06/2022
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.
Recalling firm
- Firm
- Green Lumber Holdings, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2855 E Coast Hwy Ste 228, N/A, Corona Del Mar, California 92625-2200
Distribution
- Quantity
- approx. 30,000 capsules
- Distribution pattern
- United States and Canada. Only email addresses were provided, no physical address information was received.
Timeline
- Recall initiated
- 2019-10-22
- FDA classified
- 2019-11-15
- Posted by FDA
- 2019-11-13
- Terminated
- 2023-03-22
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0351-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.