Fed Seize Contaminated Blood Thinner From China

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Federal agents have seized quantities of a contaminated blood thinner made in China from a small manufacturer in Cincinnati, officials said.

The blood thinner heparin, given to patients undergoing heart surgery and kidney dialysis, was the focus of a major recall earlier this year after crude drug material from China was found to be contaminated with chondroitin sulfate. Hundreds of frail patients suffered severe allergic reactions, and nearly 250 died.

 

The FDA's handling of the contamination scandal has drawn criticism and sparked congressional inquiry.

The agency inspected the Cincinnati company, Celsus Laboratories, in April and at that time found contaminated heparin in two different kinds of products. A little over two pounds of the blood thinner was intended for use directly with patients, and another 31 pounds was to be utilized in diagnostic test kits and medical devices.

The FDA seized the heparin after informing the company that its efforts to notify customers of the contamination problem were unsatisfactory. Drug seizures are a rare penalty for the FDA, since regulators prefer to negotiate with manufacturers to resolve disputes.

 

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