News & Press: Patient Safety

Patients Exposed to Risk From Drugs Made and Distributed by Compounder PharMEDium Services

Thursday, May 23, 2019  

SIS Patient Safety Alert 05/23/2019: United States Federal Court Enters Consent Decree Against Compounder PharMEDium Services for Violations at Facilities in Mississippi, New Jersey, Tennessee, and Texas.

This is an important alert from the Spine Intervention Society. SIS sends Patient Safety Alerts when it receives important information regarding products or services that can impact your patients' safety. When the Food and Drug Administration (FDA) issues a safety alert, or a company announces a recall or market withdrawal, the FDA posts the announcement as a public service. In such cases neither SIS nor the FDA endorse either the product or the company.

The FDA issued notice on May 22, 2019 that U.S. District Judge Virginia M. Kendall for the Northern District of Illinois entered a consent decree of permanent injunction today between the United States and PharMEDium Services, LLC, headquartered in Lake Forest, Illinois, as well as Scott Aladeen, the company’s president, and Warren Horton, vice president for Quality and Research and Development. The company has four registered outsourcing facilities located in Memphis, Tennessee; Cleveland, Mississippi; Sugar Land, Texas; and Dayton, New Jersey. According to the complaint, despite previous warnings from the FDA and repeated promises from PharMEDium to correct deficiencies, PharMEDium continued to violate the law.

“PharMEDium exposed patients across the United States to risk of receiving a harmful drug, which we find unacceptable,” said Acting FDA Commissioner Ned Sharpless, MD. “We will continue to take appropriate enforcement actions when compounding pharmacies and outsourcing facilities produce drugs under substandard conditions or use inappropriate practices that could lead to serious harm to patients.”

The consent decree prohibits PharMEDium and the other defendants from, among other things, manufacturing, holding, or distributing PharMEDium’s drugs at or from its Tennessee facility until it completes corrective actions and receives authorization from the FDA. The company has ceased operations at its Mississippi facility, and its Texas and New Jersey facilities must, among other things, hire an independent expert to review PharMEDium's operations at these facilities to ensure compliance with the law.

In the complaint, the government alleges that PharMEDium manufactured and distributed drugs intended to be sterile such as oxytocin and morphine sulfate, that were adulterated because the drugs were made under insanitary conditions and in violation of current good manufacturing practice requirements under the FD&C Act. Drugs prepared, packed or held under insanitary conditions may have been contaminated with filth or may have been rendered injurious to health. The complaint also alleges that PharMEDium distributed unapproved new drugs and drugs that were misbranded because their labeling did not bear adequate directions for use.

The FDA conducted multiple inspections at PharMEDium’s corporate headquarters and outsourcing facilities between 2013 and 2018 that resulted in a warning letter for insanitary conditions and other violations of the FD&C Act. An additional warning letter was issued in 2007 for similar violations.

The U.S. Department of Justice filed the complaint on behalf of the FDA.

SIS previously alerted interventional specialists about issues with this compounding pharmacy on January 11, 2018, January 2, 2018, and May 9, 2016. Follow SIS on Facebook, Instagram, LinkedIn, and Twitter for information on important patient safety issues as they arise.

Source: Food and Drug Administration - Accessed 05/23/2019

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