The FDA is alerting 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.
Health care professionals should immediately check their medical supplies, quarantine any drug products marketed as sterile from Pharmakon, and not administer them to patients. Administration of a non-sterile drug product intended to be sterile may result in serious and potentially life-threatening infections or death.
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. FDA test results showed the product to be nearly 2,500 percent the labeled potency. During the inspection, investigators observed insanitary 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, 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 FDA that it would neither initiate a recall nor cease sterile production. Therefore, 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. Patients who have received this drug product and have concerns should contact their health care professionals. To date, FDA is not aware of any additional reports of illness associated with the use of these products.
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, 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.
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