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B. Braun Voluntarily Recalls Seven Lots of Heparin Manufactured in 2008 Due to Supplier-Initiated Recall of Heparin Active Pharmaceutical Ingredient (API)
Date:10/27/2010

parin in 0.9% Sodium Chloride Injection, 2 Units/mL

P8721

J8D702

4/30/2008

10/31/20101,000 Units Heparin in 0.9% Sodium Chloride Injection, 2 Units/mL

P8721

J8D703

4/30/2008 – 5/1/2008

10/31/201025,000 Units Heparin in 5% Dextrose Injection, 50 Units/mL

P5771

J8E462

5/8/2008

11/30/20101,000 Units Heparin in 0.9% Sodium Chloride Injection, 2 Units/mL

P8721

J8E539

5/15/2008

11/30/2010B. Braun is notifying its distributors and customers by certified mail and is arranging for return of all recalled product. Customers who have product from the recalled product lots in their possession should discontinue use immediately. Patients reporting any problems that may be related to the use of this product should be advised to contact a physician. Customers may contact B. Braun Medical Inc. Customer Support Department at 800-227-2862 Monday through Friday, 8 a.m. to 7 p.m. ET for instructions for handling the affected product and to arrange for replacement product.  

Adverse reactions or quality problems experienced in the U.S. with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

  • Online: www.fda.gov/medwatch/report.htm
  • Regular Mail: Use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form.
  • Fax: 1-800-FDA-0178 

  • About B. BraunB. Braun is a leading manufacturer of infusion therapy and pain management products with an environmentally-friendly focus. Guided by the company's "Sharing Expertise®" philosophy, B. Braun addresses the critical issues of infection prevention, medication safety and '/>"/>

    SOURCE B. Braun Medical Inc.
    Copyright©2010 PR Newswire.
    All rights reserved

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