FDA consent decree nails Shamrock Medical

The FDA has taken to the courts to close a drug company with persistent quality issues for the second time in three weeks. The FDA got a consent decree of permanent injunction against Shamrock Medical Solutions Group, four of its officers and its employees for continually shipping to hospitals drugs that had been mislabeled.

Owners of the Lewis Center, OH, company have assured authorities that Shamrock is no longer repackaging or distributing any drugs. Under the terms of the court order, it cannot start up again without FDA's approval.

The agency a year ago issued a warning letter to Shamrock for repeatedly allowing technicians to access the company's master labeling program after promising not to. That led to the company distributing mislabeled products including the thyroid medication levothyroxine, blood pressure medication diltiazem and heartburn medication metoclopramide. Shamrock had received complaints from customers that some products, including oxycodone hydrochloride and 7 lots of morphine sulfate oral solution, contained air bubbles and had low fill volumes.

In April, the FDA says it sent an alert to healthcare providers to jettison any drugs they had gotten from Shamrock because they might be mislabeled. The agency said it never received any reports of adverse events but that didn't excuse Shamrock from failing to do it right.

"This company continued to distribute mislabeled drugs despite previous warnings by the FDA," Melinda Plaisier, FDA associate commissioner for regulatory affairs said. "We will take swift, aggressive enforcement action against firms that violate the federal law."

The agency last month prescribed the same kind of legal remedy for Mitchell, SD-based Dakota Laboratories and its owner Charles Voellinger. The suit came after inspections in 2010, 2011 and 2012 found significant manufacturing lapses in the plant's production of eye drops. That company also abandoned its business in the face of the legal action.

- here's the announcement