News Tagged ‘heparin seizure

Congressman questions FDA’s slow action on heparin seizure

A Texas congressman is questioning why the waited six months to seize lots of contaminated heparin from an Ohio company, according to CNN Money.

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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.

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Contaminated heparin removed from Cinnicinnati plant

The U.S. Food and Drug Administration () 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 has determined five lots of Heparin Sodium Active Pharmaceutical Ingredient (API) and six lots of Lithium were contaminated with over-sulfated chondroitin sulfate (ASCS). The products were manufactured from material imported from .

The ordered U.S. Marshals to seize the products today. Mike Chappell, acting associate commissioner for regulatory affairs for the is quoted as saying, “This action will help prevent this contaminated heparin from finding its way into the marketplace.”

Earlier this year, manufactured by Baxter International, Inc., was found to be contaminated with OSCS. That also contained components manufactured in , which is believed to be the source of the contamination. The Baxter contamination led to hundreds of injuries and 81 deaths.

The news release states that the agency has initiated 13 recalls of multiple contaminated medical products containing from several companies, to date this year.

Information in the news release indicates the Celsus entered the United States before the establishment of import controls for the drug, and was reviewed by the after it was processed at Celsus as a part of the agency’s process to implement the controls.

The release also indicates that the knew about the contamination in April 2008, when it warned Celsus Laboratories during an inspection that the company’s actions to notify customers about the contaminant were insufficient. The says it warned Celsus again that it needed to step up its efforts to notify customers about the potential hazard in a May 8, 2008 letter. Finally, today the seized the contaminated product from the lab.

Manufacturers who may have purchased from Celsus are urged to contact the company immediately to make sure they are not using any from the since-seized lots. The product does not meet acceptable quality standards, the release says.