REGULATORY INTELLIGENCE·Warning Letter
FDA Class I Recall: Pyramids Wholesale Inc. Pulls "Flower Power" Over Undeclared Sildenafil and Tadalafil
Pyramids Wholesale Inc. initiated a Class I FDA recall (D-0450-2024) for its "Flower Power, CBD infused Female Enhancement" product due to undeclared sildenafil and/or tadalafil, marketed without an approved NDA/ANDA. This event underscores critical supply chain and regulatory compliance risks for businesses. Procurement and regulatory affairs must enhance due diligence to avoid sourcing or distributing adulterated products, ensuring robust quality control and adherence to FDA approval pathways.
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