November 10, 2008
In a step rarely taken, the U.S. Food and Drug Administration (FDA) today sent U.S. Marshals to seize 11 lots of heparin from a Cincinnati-based medical products manufacturer that twice refused to obey orders to recall the contaminated blood-thinning drug.
The company, Celsus Laboratories, distributes heparin to drug and medical products manufacturers both in the United States and internationally.
Tests conducted by the FDA in January found that large amounts of raw heparin imported from China into the United Sates were contaminated with the chemical oversulfated chondroitin sulfate. The chemical, a shellfish-based compound able to replicate the effects of heparin, is believed to have been added by Chinese factories to cut costs.
Although a massive heparin recall was issued after the contamination was discovered, approximately 250 deaths and hundreds of severe allergic reactions have been blamed on tainted batches of heparin, which is frequently given to patients during heart surgery and kidney dialysis to prevent blood clots.
The two Celsus products seized by government officials were heparin sodium and heparin lithium. The sodium form is given directly to patients as a blood thinner and the lithium form is used to coat medical devices, such as blood collection tubes, to prevent clotting. The seized heparin is worth around $112,000.
According to the FDA, the contaminated heparin at Celsus Laboratories was first discovered in April during an inspection. Although the company sent a letter to its customers telling them its heparin was contaminated, the FDA wanted Celsus to physically recall the product because of the danger it presented to patients.
Because the U.S. Marshals were only able to seize the contaminated heparin that remained in Celsus Laboratories’ facilities, those who may have already purchased heparin from Celsus are advised by the FDA to contact Celsus to make certain they are not using any heparin from the seized lots.
Heparin Side Effects Lawyers
If you or a loved one has been exposed to contaminated heparin and has experienced health problems as a result, consult a personal injury attorney who specialized in heparin lawsuits. You may be entitled to financial compensation for your injuries and losses.
Contact us today for a free and confidential case evaluation.
