U.S. Marshalls Seize Tainted Heparin In Ohio
The U.S. marshals sent by the Food and Drug Administration seized some supplies of contaminated blood thinner containing material from China, from an Ohio company’s supplies. Eleven lots of heparin from Celsus Laboratories Inc. of Cincinnati were seized from the company that distributes heparin to drug and medical-device manufacturers both in the United States and internationally.
Mike Chappell, the FDA's acting associate commissioner for regulatory affairs said, "This action will help prevent this contaminated heparin from finding its way into the marketplace."
The FDA during testing in January found that large amounts of Chinese raw heparin, which were imported to the U.S., were contaminated with over-sulfated chondroitin sulfate (OSCS), a substance that mimics heparin's anti-clotting activity, the agency said.
OSCS, a compound made from animal cartilage, is linked to serious adverse events, including allergic reactions causing nausea, vomiting, shortness of breath, a severe drop in blood pressure and death. The blood thinner is frequently given to patients undergoing heart surgery and kidney dialysis.
The FDA said the substance was added to make the product pass the test done to measure heparin levels. Almost 250 deaths and hundreds of severe allergic reactions were blamed on tainted batches of heparin which resulted in a major heparin recall.
Heparin sodium and heparin lithium, both Celsus products were recalled. Heparin lithium is used to coat medical devices, such as blood-collection tubes, to keep blood from clotting on them and 31 pounds and six of the lots seized were of the product.
Five of the lots, just over 2 pounds of heparin sodium was seized which represented only a portion of the full 11 lots, which had already been shipped to other manufacturers. The seized heparin was worth about $112,000.
The FDA said it inspected Celsus Laboratories in April and found that two of its heparin products were contaminated. In a follow-up letter to the company on May 8 the FDA again asked for a recall.
Agency spokeswoman Karen Riley said, as the FDA had warned companies earlier, the drug was never used and no patients were put at risk. On Thursday the federal marshals seized the remaining contaminated heparin from the company’s facilities said Riley.
Riley added that Celsus imported the raw heparin from Changzhou SPL. The seized material entered the country before the import controls were established this year.
FDA said it has also advised manufacturers who might have bought heparin from the company to contact the agency to make sure they don't have any of the contaminated heparin. "The product does not meet acceptable quality standards," the agency said.
In addition, the agency has also notified Japan, Canada, Australia, the European Union and other countries to be on the watch for shipments of contaminated heparin from Celsus.