FDA advises health care professionals not to use Pharmakon products marketed as sterile

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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” FDA (2016).

FDA report “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.”

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