Safety Alerts & Recalls

What does this mean?

This recall for Heparin from B. Braun was issued at a warehouse and healthcare provider level only. The FDA and the manufacturer have determined that any recalled product that may have been administered to patients does not pose a significant health risk. If you are concerned about the heparin product you have been receiving, you should speak to your doctor or other healthcare provider.

B. Braun Recalls Several Lots of Heparin

B. Braun Medical Inc. (B. Braun) is issuing a nationwide recall of Heparin because testing of samples of the active ingredient found trace amounts of the contaminant oversulfated chondroitin sulfate. B. Braun has not received any reports of adverse events regarding B. Braun finished heparin products. However, as a precaution B. Braun is initiating a voluntary recall of seven lots of heparin injection products to the healthcare provider level. These lots were manufactured in 2008 and will be expiring on October 31, 2010 and November 30, 2010.

The following B. Braun products and lot numbers have been recalled: 25,000 Units Heparin in 5% Dextrose Injection, 50 Units/mL, lot numbers J8D674 and J8E462

1,000 Units Heparin in 0.9% Sodium Chloride Injection, 2 Units/mL, lot numbers J8D676, J8D677, J8D702, J8D703, and J8E539

Heparin is a blood thinner used to treat and prevent blood clot

For more information, please visit: more information here

Source: FDA
Publication Date: 2010-11-01
Last Updated: 2010-11-01

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