The U.S. Food and Drug Administration announced today that federal judge Algenon L. Marbley of the Southern District of Ohio has approved a consent decree of permanent injunction against Shamrock Medical Solutions Group, LLC, of Lewis Center, Ohio, and four of its corporate officers and employees for continued drug manufacturing and labeling violations that resulted in the distribution of mislabeled drugs.
Shamrock Medical repackages and distributes solid and liquid oral non-sterile drug products for human use to hospitals throughout the country. Recent FDA inspections found several violations at the facility, including failure by the quality control unit to fully follow its own quality control procedures and to examine packaged and labeled products to ensure correct labeling. The FDA has previously sent warning letters to Shamrock Medical for violating current good manufacturing practices (CGMP) and distributing incorrectly labeled drugs.
This announcement follows an FDA alert issued in April 2013 advising health care providers to remove drugs distributed by Shamrock Medical from supply stock due to the possibility that they were mislabeled. The warning covered many non-sterile medications and dosage forms, including tablets, vials, ophthalmic and otic solutions, and patches.
Shamrock Medical’s representatives have informed the court that they are no longer repackaging or distributing any drugs “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.”
According to the consent decree, if Shamrock Medical decides to resume operations, the company must first notify the FDA of their intentions. The firm will not be able to resume operations until they receive written notice from the FDA that their operations are compliant with the Federal Food, Drug, and Cosmetic Act and all applicable regulations. Prior to resuming operations, the consent decree also requires Shamrock Medical to retain an independent expert to inspect their operations and have the expert certify to the FDA that the necessary corrections have been made. The consent decree also requires Shamrock Medical, upon resumption of its operations, to comply with CGMP 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.”
The agency has not received reports of harm to patients from use of these drug products at this time, and no drug shortage is anticipated as a result of today’s consent decree.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.