November 7, 2008 |
U.S. marshals seized 11 contaminated lots of the blood-thinner heparin made from Chinese ingredients by a maker that ships to drug and device manufacturers in several countries. The marshals took the drugs from closely held Celsus Laboratories Inc. in Cincinnati, the Food and Drug Administration said. The action followed unsuccessful efforts to persuade the company into an "effective" recall, the FDA said.
April 9, 2008 |
The scope of concerns about the possible ill effects of a contaminated blood thinner from China grew significantly Tuesday as federal regulators urged makers of many kinds of medical devices that contain the drug to test their supplies. The products to be tested cover a spectrum of equipment and uses.
March 15, 2008 |
The investigation into a blood thinner suspected in some 19 U.S. deaths is now focusing on the possibility that raw biological ingredients were contaminated even before they reached a factory in China, manufacturer Baxter Healthcare Corp. said Friday. That raises the prospect that the problem could have occurred somewhere along a supply chain that includes layers of middlemen and originates in pig farms. Heparin, a generic medication, is derived from a substance in the lining of pig intestines.
February 29, 2008 |
Baxter International Inc. said Thursday that it had recalled the remaining lots of its troubled blood-thinning drug heparin as U.S. regulators reported "objectionable conditions" at the Chinese factory that supplied the raw ingredient for the drug. Heparin has been linked to four deaths and hundreds of adverse reactions and is the subject of an investigation by the Food and Drug Administration. It is not known whether the Chinese plant is the cause of the problems, the FDA said.
February 26, 2008 |
Li Li, a drug industry veteran, spent almost five years getting his heparin plant ready for U.S. regulatory approval. It was an arduous process, he said, displaying thick black binders with detailed documentation of his operations here. And his timing couldn't have been better. Heparin, a widely used blood thinner, was once made from cow lungs. Drug makers shifted to pig intestines as concerns over mad cow disease heightened in the 1990s, and no place has more hogs than China.
February 20, 2008 |
The maker of a blood thinner suspected in four U.S. deaths and allergic reactions in 350 people said Tuesday that its investigation was focusing more closely on whether something went awry during the processing of ingredients in China. Baxter Healthcare Corp. spokeswoman Erin Gardiner said testing had detected irregularities in samples of the drug, heparin, that were processed in China from raw material extracted in China.