REGULATORY INTELLIGENCE·Warning Letter
FDA Class I Recall: Green Lumber Holdings' Unapproved 'Natural Fuel For Men' Capsules Contain Undeclared Tadalafil
Green Lumber Holdings, LLC initiated a nationwide Class I recall for its 'Green Lumber Natural Fuel For Men' capsules. The FDA detected tadalafil, an undeclared API, in the unapproved product. This event underscores critical regulatory and supply chain risks for businesses distributing or sourcing products without proper FDA clearance, demanding enhanced due diligence and compliance verification.
90-Day Activity