The United States Food and Drug Administration (FDA) has recalled seven lots of heparin manufactured in 2008 and known as Heparin Sodium USP Active Pharmaceutical Ingredient (API), which were sold to Braun Medical Inc. for distribution. Heparin is a drug that is used to thin the blood and prevent blood clots. The medicinal product was recalled because it was contaminated with oversulfated chondroitin sulfate (OSCS).
The FDA hasn’t received any reports of adverse reactions due to the OSCS in the product, but they are recalling it as a precaution. They don’t think it will cause "significant" risk, although it has a potential risk.
The affected lots are: 25,000 Units Heparin in 5% Dextrose Injection, 50 Units/mL P5771 J8D674 4/15/2008 10/31/2010
1,000 Units Heparin in 0.9% Sodium Chloride Injection, 2 Units/mL P8721 J8D676 4/17/2008 10/31/2010
1,000 Units Heparin in 0.9% Sodium Chloride Injection, 2 Units/mL P8721 J8D677 4/17/2008 10/31/2010
1,000 Units Heparin in 0.9% Sodium Chloride Injection, 2 Units/mL P8721 J8D702 4/30/2008 10/31/2010
1,000 Units Heparin in 0.9% Sodium Chloride Injection, 2 Units/mL P8721 J8D703 4/30/2008 – 5/1/2008 10/31/2010
25,000 Units Heparin in 5% Dextrose Injection, 50 Units/mL P5771 J8E462 5/8/2008 11/30/2010
1,000 Units Heparin in 0.9% Sodium Chloride Injection, 2 Units/mL P8721 J8E539 5/15/2008 11/30/2010.
B. Braun is notifying its customers about how to return the affected product. If you have any concerns you can contact B. Braun’s customer services team at: 800-227-2862. If you have suffered an adverse event please report it to: www.fda.gov/medwatch/report.htm