The heparin recall broadens again. Another manufacturer, B. Braun Medical, said it was recalling 23 lots of the blood thinner as a precautionary measure. No adverse events have been reported in connection with its product, the company said. But Braun buys some of its heparin ingredient from Scientific Protein Laboratories, the same company that supplies Baxter Healthcare--the same company whose Chinese-sourced ingredient was tainted with chemical that mimics heparin.
At the same time, American Health Packaging recalled some Baxter heparin vials that it had repackaged for use in pharmacy automation equipment. Hospitals that bought those vials were notified last month.
Baxter, of course, recalled nearly all its heparin products in the U.S. after the med was linked to severe allergic reactions and deaths. Since then, scientists have found oversulfated chondroitin sulfate in suspect batches. Investigators are still trying to figure out how the chemical got into the drug.
Meanwhile, China's top drug watchdog is ordering local bureaus to step up their oversight of heparin production. China's SFDA says producers now have to get their raw material from registered suppliers, and suppliers have to use more rigorous checks on quality and safety. That's an about-face; previously, the agency had said that importing countries bore responsibility for ensuring heparin's safety. But it's still unclear how SFDA intends to supervise the thousands of small workshops that gather raw materials for heparin from pig intestines.
- find the press release on Braun's recall
- read the AHP recall release
- see the WSJ story on the recall
- check out the China article in the New York Times
ALSO: Cedars-Sinai Medical Center was fined $25,000 by California regulators for giving overdoses of heparin to Dennis Quaid's newborn twins and one other infant. The Quaids' lawsuit against heparin maker Baxter Healthcare remains outstanding. Report
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Heparin mimic found in suspect samples. Report
FDA moves to allay drug-import fears. Report