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FDA’s search of the defendant company produced large heart pill

26 June 2009 1,102 views No Comment

The Food and Drug Administration today has seized products from a company that makes heart pills and other drugs which in the past have been found to be over-sized and carry potentially deadly overdoses of active ingredients.
Caraco Pharmaceutical Laboratories Ltd is accused of repeatedly failing to conform to the FDA’s Good Manufacturing Practices, which are rules designed to assure that manufactured drugs are safe. Federal marshals, under the direction of the FDA, raided three Caraco facilities in Michigan, seizing drugs and drug ingredients held there, officials said.

“The FDA is committed to taking enforcement action against firms that do not manufacture drugs in accordance with our good manufacturing practice requirements,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “Compliance with these standards prevents harm to the public.”
Earlier Recalls Announced
In the past year, Caraco has announced several recalls of drug products which, due to manufacturing defects, were oversized tablets with potentially dangerous amounts of active ingredients.

In March, the company recalled several of its digoxin tablets after the pills were found to be larger than normal. Digoxin is taken to treat heart failure and arrhythmia (irregular heart beat) and an overdose of the drug can be deadly.

In May, more Caraco digoxin pills were ordered recalled due to concerns about the large size of the tablets and suspected irregularities in the doses.
Inspections Find Continuing Problems
Recent FDA inspections of Caraco facilities found ongoing violations of federal drug-safety regulations, authorities said. An FDA news release said the raid and seizure are “intended to lead to major changes at Caraco’s facilities.”

The FDA is continuing to monitor Caraco’s operations in an effort to ensure the safety of drug products produced there in the future.

“The FDA will continue to take swift, aggressive enforcement action when firms are identified as being in violation of our manufacturing requirements,” said Michael Chappell, FDA acting associate commissioner for regulatory affairs.

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