Quality Issues Raised by FDA Concerning Pharmakon Pharmaceuticals

Pharmakon Pharmaceutical’s facility was recently inspected by the U.S. Food and Drug Administration (FDA) after 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. The products were distributed nationwide to hospitals between March 4, 20016 and April 15, 2016, according to MedWatch.

Concerns were raised regarding Pharmakon’s ability to assure the quality of the drug products and the sterility it produces. During the FDA inspection, insanitary conditions were observed, including poor sterile production practices, as well as other deficiencies. These deficiencies were environmental contamination on numerous sites with the clean rooms, including the critical ISO-5 area, 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 advises that health care professionals immediately check their medical supplies and remove any drug products from Pharmakon that are marketed as sterile and not give 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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