Drug Repackager To Halt Practices After FDA Mislabeling Suit

Law360, Washington (September 18, 2013, 4:08 PM EDT) -- The U.S. Food and Drug Administration and an Ohio drug repackaging company have struck a deal that will prevent the company from resuming its repackaging and redistributing activities until it proves it's completely fixed its long-standing processing problems, the agency said Wednesday.

According to the FDA, it repeatedly warned Shamrock Medical Solutions Group LLC about deficiencies in its drug repackaging processes and quality-control practices, culminating in an April FDA alert to health care providers and a June suit in Ohio federal court.

“This company continued to...
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Case Information

Case Title

United States of America v. Shamrock Medical Solutions Group, LLC et al

Case Number



Ohio Southern

Nature of Suit

Agriculture Acts


Algenon L. Marbley

Date Filed

June 20, 2013

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