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Empower Pharmacy, a registered outsourcing facility, produced adulterated drug products that failed to meet the conditions required under section 503B of the Federal Food, Drug, and Cosmetic Act to qualify for exemptions from drug approval requirements. FDA investigators inspected the facility from August 1-28, 2024, and identified serious deficiencies in practices for producing drugs intended to be sterile, creating patient safety risks and violations of current good manufacturing practices. The company recalled Pyridoxine HCL Injection Solution (lot 609763) in September 2024 following the inspection findings.