Federal agents announced Thursday they have seized some of an Ohio company's supplies of tainted heparin containing made in China.
The Food and Drug Administration asked federal marshals to seize 11 lots of the blood thinner drug from Celsus Laboratories Inc. of Cincinnati that were contaminated with over-sulfated chondroitin sulfate (OSCS), a heparin-like substance. Five of the 11 lots were heparin sodium active pharmaceutical ingredient, used in finished drug products. More than 2 pounds of it was seized. The rest of the lots were heparin lithium, a substance used to coat medical devices. The federal authorities seized roughly 31 pounds of that.
The seizure that took place Thursday “will help prevent this contaminated heparin from finding its way into the marketplace," Mike Chappell, the FDA's acting associate commissioner for regulatory affairs, said in a press statement. The seized amount of the blood thinner heparin was worth about $112,000.
Earlier in 2008, there was a major recall of heparin after health officials found tainted crude drug material exported from China. Due to the contamination, hundreds of patients taking the blood thinner drug experienced severe allergic reactions. What’s more, there have also been reported an estimated 250 deaths.
Containing ingredients extracted from pig intestines, heparin is used to prevent blood clots in millions of people with heart conditions, kidney disease and in surgery. One of the oldest drugs, it has been discovered in 1916 but didn’t enter clinical trials until 1935.
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