Pharmakon Pharmaceuticals, Inc. is voluntarily recalling all lots of sterile products aseptically compounded and packaged by Pharmakon Pharmaceuticals, Inc. that remain within expiry due to the Food and Drug Administration’s (FDA) concern over a lack of sterility assurance and other quality issues. Administration of a sterile drug product intended to be sterile that is compromised may result in serious and potentially life-threatening infections or death. To date, Pharmakon Pharmaceuticals, Inc. has not received any reports of adverse effects or injuries.
About The FDA
The Food and Drug Administration (FDA) is an agency within the U.S. Department of Health and Human Services. It consists of the Office of the Commissioner and four directorates overseeing the core functions of the agency: Medical Products and Tobacco, Foods and Veterinary Medicine, Global Regulatory Operations and Policy, and Operations.
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