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

2:13-cv-00590

Court

Ohio Southern

Nature of Suit

Agriculture Acts

Judge

Algenon L. Marbley

Date Filed

June 20, 2013

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