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Celsus Laboratories 5 articles

FDA commissioner announces plans to resign next month

The Associated Press reported today that Food and Drug Administration Commissioner Dr. Andrew von Eschenbach will resign from his post effective Jan. 20, the same day president-elect Barack Obama takes office. Von Eschenbach was appointed by President Bush in 2005 after the agency’s previous commissioner resigned due to ethical issues, the AP reports. While under von Eschenbach’s helm, the FDA has undergone scrutiny by Congress and consumer groups over issues such as the tainted heparin scandal earlier this year. The FDA ordered a recall on batches of the blood thinner heparin made at Baxter International’s Chinese facility after some lots ... Read More

Congressman questions FDA's slow action on heparin seizure

A Texas congressman is questioning why the FDA waited six months to seize lots of contaminated heparin from an Ohio company, according to CNN Money. Earlier this year, the FDA recalled lots of heparin manufactured in a Baxter International Chinese plant after batches were found to have been contaminated with over-sulfated chondroitin sulfate. The FDA recall was the result of an investigation into the deaths of more than 80 people and illnesses of hundreds more people after receiving doses of heparin. CNN Money reports that the recall process is voluntary. Companies are not required to immediately comply with the FDA’s ... Read More

Time shares story of family affected by heparin contamination

A recent Time magazine story gives us a glimpse into a family affected by the contaminated heparin tragedy: Leroy Hubley’s wife of 48 years, Bonnie, suffered from polycystic kidney disease, a genetic kidney disease in which cysts grow in the kidneys, causing them to fail. She received a kidney transplant in October 2007, but her body rejected it, leaving her in need of regular dialysis treatments. During dialysis, patients are hooked up to a machine that draws out the blood through tubing. Since blood tends to clot when it moves through the tubing, patients routinely are given the blood thinner ... Read More

Doctors outraged by heparin seizure

ConsumerAffairs.com is reporting that doctors are outraged that recalled batches of heparin were found in a Cincinnati, Ohio lab. “It’s really horrible for two reasons: one, that a company that knows that their product is not a good product that should be distributed and they’ve been told so,” said Dr. Lynne Wagoner, a Christ Hospital Heart Specialist, who was quoted in the story by WTOL-TV in Toledo, Ohio. Earlier this month, U.S. Marshals seized a total of 11 lots of the blood thinner at Celsus Laboratories Inc. Heparin was recalled earlier this year after an FDA investigation found that batches ... Read More

Contaminated heparin removed from Cinnicinnati plant

The U.S. Food and Drug Administration (FDA) issued and FDA NEWS release today informing the public that it has removed 11 lots of heparin from Celsus Laboratories, Inc., in Cinncinnati, Ohio. According to the release, the FDA has determined five lots of Heparin Sodium Active Pharmaceutical Ingredient (API) and six lots of Heparin Lithium were contaminated with over-sulfated chondroitin sulfate (ASCS). The heparin products were manufactured from material imported from China. The FDA ordered U.S. Marshals to seize the products today. Mike Chappell, acting associate commissioner for regulatory affairs for the FDA is quoted as saying, “This action will help ... Read More