Compliance Management

Pharmakon Pharmaceuticals Recalls Sterile Compounded Products

Apr 20, 2016

Pharmakon Pharmaceuticals Inc. is voluntarily recalling all lots of sterile products aseptically compounded and packaged by Pharmakon Pharmaceuticals that remain within expiry due to the Food and Drug Administration’s 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.

These compounded sterile products are used for a variety of indications and are packaged in bags, syringes and cad cassettes. All recalled products have a label that includes the Pharmakon Pharmaceuticals Inc. name, address and expiration date. The sterile products were distributed nationwide to hospitals between March 4, 2016, and April 15, 2016.

Read the FDA recall notice