The five lots of Heparin Sodium Active Pharmaceutical Ingredient (API) and six lots of Heparin Lithium were seized at the FDA’s request by U.S. Marshals. These products, which were manufactured from material imported from China, had been found by the agency to be contaminated with over-sulfated chondroitin sulfate (OSCS), a substance that mimics heparin’s anticoagulant activity.
Posts Tagged ‘Heparin’
Contaminated Heparin seized by Federal Marshals
Written by Sadaka Associates
Friday, 07 November 2008 10:38
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Friday, 07 November 2008 10:38
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Tainted Heparin kills 62
Written by Sadaka Associates
Wednesday, 09 April 2008 09:43
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Wednesday, 09 April 2008 09:43
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The FDA said today there have been 62 fatal allergic reactions following the use of contaminated heparin.
In the 15 months from Jan. 1, 2007 through March 31, 2008, the FDA received reports of 103 deaths following heparin use, but only 62 of the deaths were linked to one or more allergic reactions, including severe hypotension, that have been linked to contaminated heparin.
The FDA has identified as the “heparin-like” contaminant called hypersulfated chondroitin sulfate in crude heparin from Scientific Protein Laboratories’ plants in Zhangzhou, China, and Waunakee, Wis.
FDA Missed Heparin Plant Inspection in China
Written by Sadaka Associates
Tuesday, 19 February 2008 23:25
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Tuesday, 19 February 2008 23:25
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A mix-up with similar names meant the FDA did not inspect a Chinese plant that makes the active ingredient in the heparin products linked to a recent spike in adverse events.
The mix-up wasn’t discovered until recently and an FDA inspection team is now headed to China to remedy the lapse, FDA officials said today in a press conference.
In principle, a foreign plant that makes an active pharmaceutical ingredient for use in products sold in the U.S. is inspected before the product is approved, said Joseph Famulare, deputy director of the Office of Compliance for the FDA’s Center for Drug Evaluation and Research.
But if the plant has been recently inspected for another product, the agency may rely on paperwork from the previous inspection, Famulare told reporters.
The Changzhou SPL plant in China, which makes the active ingredient in Baxter Healthcare’s multiple-dose vials of heparin sodium, had not been inspected and should have been, Famulare said.