By Sadie Hunter
Pharmakon Pharmaceuticals Inc. and Pharmakon Long Term Care Pharmacy Inc. have announced plans to lay off nearly 200 of its employees between the two companies.
Headquartered in Noblesville, the pharmaceutical company provides pharmacy services to extended-care facilities.
In two notices received Sept. 27 by the Indiana Dept. of Workforce Development, the company’s CEO and owner, Paul Elmer, stated the mass layoff would take effect Sept. 30.
“And this layoff, unfortunately, is expected to be permanent,” Elmer stated in the notice.
Issues stemming from an FDA investigation resulted in the layoff of 15 of the total 195 employees affected.
In February, Pharmakon recalled its production of a type of morphine sulfate because the product was “super-potent,” according to the FDA.
“Injecting a patient with super-potent morphine could result in serious consequences including respiratory depression, coma and death,” a Feb. 16 announcement from the FDA stated.” On February 16, 2016, the FDA was alerted of serious adverse events in three infants associated with the use of the recalled morphine sulfate products from Pharmakon.”
This recall resulted in the FDA investigation mentioned by Elmer in the Sept. 27 notice to the Indiana Dept. of Workforce Development.
“FDA test results showed the product to be nearly 2,500 percent the labeled potency,” an April 15 press release from the FDA stated. “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.”
Weeks later, Pharmakon held another nationwide, voluntary recall of “drug compounded products” (the combining two or more drugs) that were intended to be sterile. The recall was done “due to a lack of sterility assurance and other quality issues,” a May 5 announcement from the FDA stated.
But the majority of the layoffs, Elmer said, were the result of how the company “unexpectedly lost a major client.” A total of 180 – of 200 employees overall – will be laid off from the Pharmakon Long Term Care Pharmacy company.
Pharmakon made news in January upon the completion of the moving of its headquarters from Carmel to Noblesville, a process that began in September 2013. At that time, the company also announced its plans to hire approximately 150 additional employees by the end of 2017.