Unsterile Pharmacy with Quality Problems Refuses to Cease Production; FDA Warning

On April 15, 2016, the FDA alerted health care professionals not to 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.


Administration of a non-sterile drug product intended to be sterile may result in serious and potentially life-threatening infections or death.


The FDA recently inspected Pharmakon’s facility following the company’s voluntary recall of super-potent morphine sulfate 0.5 mg/ml preservative free in 0.9% sodium chloride, 1 ml syringe, CII, for intravenous use. The FDA test results showed the product to be nearly 2,500 percent the labeled potency. During the inspection, investigators observed unsanitary conditions, including poor sterile production practices, and other deficiencies, which raise concerns about Pharmakon’s ability to assure the sterility and quality of drug products that it produces. Additionally, FDA testing confirmed environmental contamination on multiple sites within the clean rooms, including the critical ISO-5 area.


On April 11, 2016, the FDA recommended that Pharmakon cease sterile operations until appropriate corrective actions have been implemented by the facility and recall all non-expired drug products that are intended to be sterile. On April 12, 2016, Pharmakon informed the agency that it would neither initiate a recall nor cease sterile production. Therefore, the FDA is alerting health care professionals not to use drug products marketed as sterile from Pharmakon.


Additionally, on February 16, 2016, FDA received reports of serious adverse events experienced by three infants associated with the use of the recalled super-potent morphine sulfate products from Pharmakon. Injecting a patient with super-potent morphine could result in serious consequences including respiratory depression, coma, and death.


The FDA conducted its initial inspection of Pharmakon in March 2014. A second inspection was conducted in April 2014 to follow up on adverse event reports related to super-potent midazolam products administered to neonatal infants. Based on the observations made during the 2014 inspections, the FDA issued a warning letter in May 2015. Pharmakon Pharmaceuticals, Inc. is registered under section 503B of the Federal Food, Drug, and Cosmetic Act (FDCA) as an outsourcing facility.


The Drug Quality and Security Act, signed into law on November 27, 2013, added a new section 503B to the FDCA. Under section 503B, a compounder can elect to register as an outsourcing facility. Outsourcing facilities:


  • Must comply with current good manufacturing practice requirements;
  • Will be subject to inspection by FDA according to a risk-based schedule; and
  • Must meet certain other requirements, such as reporting adverse events and providing FDA with certain information about the products they compound.


See the FDA Drug Safety Alert


See the FDA 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