Contaminated Heparin Destroyed By FDA

December 1, 2008 by Editor
Filed under: FDA 

The Food and Drug Association has taken and destroyed more of the contaminated heparin. The FDA had inspected the Cincinnati company, Celsus Laboratories, Inc., in April and at the time found contaminated heparin in two different kinds of products, officials said. A little over 2 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, the agency said in a statement. Drug seizures are a rare penalty for the FDA, since regulators prefer to negotiate with manufacturers to resolve disputes.

The corporation was suspected to be sitting on reserves of the infected material and distributing it.

A representative who answered the phone at Celsus said the company would have no comment.

Source: vtbra

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