Nationwide Recall of Hospital Products Based on Lack of Sterility Assurance

On April 19, 2016, Pharmakon Pharmaceuticals, Inc. recalled all lots of sterile products compounded and packaged by Pharmakon Pharmaceuticals, Inc. that remain within expiry due to the FDA’s concern over a lack of sterility assurance and other quality issues. Administration of a drug product intended to be sterile that is compromised may result in serious and potentially life-threatening infections or death.


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.


Pharmakon Pharmaceuticals, Inc. notified its customers that received sterile compounded products. All hospitals that received sterile compounded products from Pharmakon Pharmaceuticals, Inc. between March 4, 2016, and April 15, 2106, and that remain within expiry, are asked to discontinue use of the products, quarantine any unused product and contact the company.


This follows the FDA’s recommendation on April 15, 2016, that health care professionals not use any drug products that are intended to be sterile and are produced and distributed nationwide by Pharmakon Pharmaceuticals Inc., in Noblesville, Indiana, due to a lack of sterility assurance and other quality issues.


See the Recall


See the FDA Drug Safety Alert


See the FDA Medical Product Safety Alert


See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication


See also Medical Law Perspectives, January 2014 Report: Prescription Painkillers: Risks for Patients, Pharmacists, and Physicians