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heparin seizure 3 articles

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

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