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FDA Warns of Quality Issues Concerning Pharmakon Pharmaceuticals

May 26, 2016

The United States Food and Drug Administration (FDA) inspected Pharmakon Pharmaceutical's facility following the company's voluntary recall of super-potent morphine sulfate 0.5 mg/ml preservative free in 0,9 percent sodium chloride, 1 ml syringe, CII, for intravenous use. FDA test results showed the product to be nearly 2,500 percent the labeled potency, according to MedWatch.

Concerns were raised regarding Pharmakon's ability to assure the quality of the drug products, and the sterility it produces. Unsanitary conditions were observed during the FDA inspection, including poor sterile production practices, as well as other deficiencies. These deficiencies were environmental contamination on numerous sites within the clean rooms, including the critical ISO-5 area. The products were distributed nationwide to hospitals between March 4, 2016 and April 15, 2016, according to the FDA website.

The FDA recommended that the Noblesville, Indiana based Pharmakon cease sterile operations as of April 11, 2016 until proper corrective actions have been implemented by the facility, as well as recall all non-expired drug products that are intended to be sterile. On April 12, 2016, Pharmakon said it would not recall or cease sterile production. As a result, the FDA is alerting health care professionals not to use drug products marketed as sterile from Pharmakon Pharmaceuticals, Inc.

The FDA recommends that health care professionals immediately check their medical supplies and quarantine any drug products from Pharmakon that are marketed as sterile and not administer them to patients. Use of a non-sterile drug product meant to be sterile may result in serious or potentially life-threatening infections or death, reports MedWatch.

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