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Empower Pharma, a registered outsourcing facility, was warned for producing adulterated drug products that failed to meet the conditions required under section 503B of the Federal Food, Drug, and Cosmetic Act to qualify for compounding exemptions. During an inspection from August through August 2024, FDA investigators identified serious deficiencies in the facility's practices for producing sterile drug products, including failures to comply with conditions necessary for outsourcing facility status, which put patients at risk. The company voluntarily recalled Pyridoxine HCL Injection Solution, 100mg/mL (lot 609763) in September 2024 following the inspection findings.