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ProRx, LLC, an outsourcing facility registered to compound sterile drug products, produced adulterated drugs that failed to meet the conditions required under section 503B of the Federal Food, Drug, and Cosmetic Act to qualify for regulatory exemptions. During a July-August 2024 inspection, FDA investigators identified serious deficiencies in the company's practices for producing sterile drug products, putting patients at risk and resulting in the collection of evidence that the drugs violated federal law. The company ceased sterile drug production on August 7, 2024, and subsequently initiated a voluntary recall of sterile drug products on August 22, 2024, due to lack of sterility assurance.