Pharmakon Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of All Sterile Compounded Products Due to FDA Concern of Lack of Sterility Assurance

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Pharmakon Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of All Sterile Compounded Products Due to FDA Concern of Lack of Sterility Assurance

04/19/2016 06:15 PM EDT

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.

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