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Last Updated: Apr 16, 2008 - 5:52:06 PM |
SATURDAY March 22, 2008 (Foodconsumer.org) -- B. Braun Medical Inc. issued a statement on March 21 saying the company started on the same day to recall 23 Finished Product lots of heparin it manufactured and distributed in the United States and to Canada.
The voluntary recall came after B. Braun was notified by its suppler, Scientific Protein laboratories LLC, based out of Wisconsin, of a nationwide recall of Heparin Sodium USP active pharmaceutical ingredient (API).
Scientific Protein Laboratories LLC has been in partnership with Changzhou SPL located in Changzhou City, China, supplying heparin active ingredient to heparin manufacturers including Baxter International.
Earlier Baxter recalled all heparin products made of the active ingredient supplied by the Chinese processor because its products have been linked to 19 deaths and more than 700 allergic reactions.
Heparin made by B. Braun has not been linked with any adverse reactions or death. The company recalled the product because the supplier notified it that one lot of the active heparin ingredient it received from the Chinese processor was contaminated with a substance that is similar to heparin.
The FDA reported early that the contaminant was found at high levels in heparin products made by Baxter. The investigation is ongoing, but the agency said it is uncertain whether the contaminant identified as oversulfated chondroitin sulfate is the cause of the deaths and allergic reactions associated with Baxter's heparin.
B. Braun listed on its website the detail of the recalled heparin including Finished Product lot number, material, and product description and other information.
For more information about heparn recalls, read FDA
and B. Braun's Supplier Recall Of Heparin API Prompts Voluntary Recall Of Heparin Solutions
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