The U.S. Food and Drug Administration (FDA) announced that a federal judge has approved a consent decree of permanent injunction against Shamrock Medical Solutions Group of Lewis Center, Ohio for manufacturing and labeling violations. The company repackages and distributes drug products to hospitals across the country.
- A consent decree is a legal agreement between the FDA and a company that has either continually received violations or has significant violations that pose a serious risk to the public. It typically requires a company to cease manufacturing and/or distribution of affected products until proof can be demonstrated to the FDA that appropriate actions have been taken to comply with applicable regulations.
- A permanent injunction order is typically issued for the purpose of requiring a person or entity to permanently stop acting in a certain manner. A court can also hand down a permanent injunction for the purpose of compelling a party to perform in a certain way.
According to reports, the FDA regulators discovered several prescription drugs had been mislabeled, including Levothyroxine, Diltiazem and Metoclopramide. In one instance, a batch of a drug incorrectly labeled as opiate painkiller morphine was in fact an oral concentrate of opioid painkiller oxycodone, which is approximately 1.5 times more potent than morphine. Shamrock was also found to have violated current good manufacturing practices by failing to have written procedures for repackaging and quality control.
The FDA had performed five comprehensive investigations of the company’s facilities since 2007, including the Lewis Center plant, and a former facility in Massachusetts. Shamrock had been issued several warning letters, but failed to take corrective actions.
“This company continued to distribute mislabeled drugs despite previous warnings by the FDA,” said Melinda K. Plaisier, the FDA’s associate commissioner for regulatory affairs. “We will take swift, aggressive enforcement action against firms that violate the federal law.”
Shamrock will not be able to resume operations until an independent expert certifies that necessary corrections have been made and the FDA sends written notice that their operations are compliant with all applicable regulations.
“Mislabeled drugs pose a serious risk to patients who rely on labeling to know what they are taking,” said Howard Sklamberg, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “These potential risks include overdose, dangerous interactions with other drugs, unnecessary exposure to toxicity, and potential side effects.
“Federal Judge approves consent decree against Shamrock Medical Solutions Group” FDA News Release, September 18, 2013.