Recall -- Firm Press Release
FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.
B. Braun Voluntarily Recalls Seven Lots of Heparin Manufactured in 2008 Due to Supplier-Initiated Recall of Heparin Active Pharmaceutical Ingredient (API)
No adverse events reported and no detectable contaminate found in testing of API or finished product
Stern + Associates for B. Braun Medical Inc.
908.276.4344 ext. 227
B. Braun Medical Inc.
FOR IMMEDIATE RELEASE - OCT. 27, 2010 - Irvine, CA - B. Braun Medical Inc. (B. Braun) was recently notified by its supplier, Scientific Protein Laboratories LLC (SPL), of a nationwide recall of a lot of Heparin Sodium USP Active Pharmaceutical Ingredient (API) sold to B. Braun because additional testing of retained crude heparin samples used by SPL to manufacture this single API lot indicated a trace amount of oversulfated chondroitin sulfate (OSCS) contaminant. As a result, 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.
B. Braun has not received any reports of adverse events regarding the B. Braun finished products manufactured using this API.
Based on current information, the recalled lots do not pose a significant health risk; however, B. Braun is performing this voluntary recall as a precautionary measure with the support of the U.S. Food and Drug Administration (FDA).
Heparin is a blood thinner used to treat and prevent blood clots. The voluntary recall affects the following seven Finished Product (FP) lots manufactured in 2008 by B. Braun Medical Inc. and distributed nationwide to distributors and direct healthcare provider customers.
|Product Name||B. Braun
|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 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