D-0351-2020 Class I Terminated
FDA drug recall D-0351-2020 was initiated by Green Lumber Holdings, LLC on October 22, 2019 and is designated Class I. 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. The recall status is terminated (terminated March 22, 2023). Affected quantity: approx. 30,000 capsules.
Recall Details
- Product Type
- Drugs
- Report Date
- November 13, 2019
- Initiation Date
- October 22, 2019
- Termination Date
- March 22, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- approx. 30,000 capsules
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.
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.
Distribution Pattern
United States and Canada. Only email addresses were provided, no physical address information was received.
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