FDA Recall D-0351-2020

Green Lumber Holdings, LLC · Corona Del Mar, CA

Class I — life-threatening Terminated 1247 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence 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.

Lot / code: Lot #: XC12, EXP 12/2020; XC06, EXP06/2021; XC10, EXP 10/2021; XC02, EXP 02/2022; XC04, EXP 04/2022; XC06, EXP06/2022

Quantity: approx. 30,000 capsules

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.

Recall record

Recall number: D-0351-2020
Classification: Class I
Status: Terminated
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: United States and Canada. Only email addresses were provided, no physical address information was received.
Recall initiated: 2019-10-22
Classified by FDA Center: 2019-11-15
FDA published: 2019-11-13
Terminated: 2023-03-22
Recalling firm: Green Lumber Holdings, LLC
Firm location: Corona Del Mar, CA

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