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Friday, March 21, 2008

B. Braun Medical Inc. Recalls Heparin Nationwide.

WASHINGTON (AP) — B. Braun Medical Inc., Another manufacturer of the blood thinner heparin initiated a nationwide recall Friday because some products may contain a potentially dangerous contaminant. Contaminated heparin from a different manufacturer, Baxrer, has been associated with 19 deaths and hundreds of allergic reactions.
In the recall announced Friday, B. Braun Medical Inc. said it was recalling 23 lots of heparin as a precautionary measure. No adverse events have been reported in connection with their product, company officials said in a press release.(This press release mentioned by AP, was not available at FDA nor at B. Braun Medical Inc. )
The company issued the recall after one of its suppliers, Wisconsin-based Scientific Protein Laboratories, disclosed that an ingredient it provided contained oversulfated chondroitin sulfate, a chemical that does not occur naturally. Federal officials are investigating how the contaminant got into the drug.
Heparin is derived from a mucus obtained from pig intestines and other animal tissues, often processed by small, unregistered workshops in China. Scientific Protein Laboratories owns a Chinese factory — Changzhou SPL — and buys additional raw heparin from other Chinese suppliers.
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