Recall -- Firm Press Release
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Baxter Initiates Voluntary Recall of One Lot of 0.9% Sodium Chloride Injection, USP Intravenous (IV) Solution
FOR IMMEDIATE RELEASE - June 24, 2014 - Baxter International Inc. announced today it is voluntarily recalling one lot of 0.9% Sodium Chloride Injection, USP 1000 mL, a portion of which was released to customers. The recall is being initiated as a result of particulate matter found near the administration port.
If infused, particulate may result in blockages of blood vessels, which can result in stroke, heart attack or damage to other organs such as the kidney or liver. There is also the possibility of allergic reactions, local irritation and inflammation in tissues and organs. There have been no reported adverse events associated with this issue to date, and the root cause of this recall has been identified and resolved.
Sodium Chloride Injection, USP is an intravenously administered injectable indicated as a source of water and electrolytes and for use as a priming solution in hemodialysis procedures. The recalled lot number is C931923, Product Code 2B1324X. A portion of this lot was distributed to 29 customers in the United States between February 27, 2014, and March 1, 2014; product was packaged in flexible plastic containers. The amount of individual units from this lot that was released to customers represents less than one-and-a-half percent of Baxter’s average daily sales of this product. Unaffected lot numbers can continue to be used according to the instructions for use.
Baxter has notified customers, who are being directed not to use product from the recalled lot. Recalled product should be returned to Baxter for credit by contacting Baxter Healthcare Center for Service at 1-888-229-0001, Monday through Friday, between the hours of 7:00 a.m. and 6:00 p.m., Central Time. Unaffected lots of product are available for replacement.
Consumers with questions regarding this recall can call Baxter at 1-800-422-9837, Monday through Friday, between the hours of 8:00 a.m. and 5:00 p.m. Central Time, or e-mail Baxter at email@example.com. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this drug product.
Adverse reactions or quality problems experienced 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.
- Complete and submit the report 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
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Baxter International Inc., through its subsidiaries, develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, cancer, infectious diseases, kidney disease, trauma and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide.
Recalled Product Photos Are Also Available on FDA's Flickr Photostream.