FDA: Mislabeling Leads to Permanent Injunction against Repackager

Failures in labeling quality control procedures reportedly have led to a permanent injunction. FDA is reporting on its Web site 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," FDA reports. "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."

Earlier this year in April, FDA advised 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," FDA reports.

Company representatives have informed the court that they are no longer repackaging or distributing any drugs, the agency writes.

“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, on its Web site. “We will take swift, aggressive enforcement action against firms that violate the federal law.”

FDA reports that "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."

Click here to read more details from FDA.

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