Baxter IV Solutions: Recall - Potential Presence of Particulate Matter

0.9% Sodium Chloride Injection, USP, 250 mL VIAFLEX Plastic Container
70% Dextrose Injection (2000 mL) USP

AUDIENCE: Pharmacy

ISSUE: Baxter International Inc. announced a voluntarily recall of two lots of intravenous (IV) solutions to the hospital/end user level due to the potential presence of particulate matter. The particulate matter in each case was determined to be an insect and was identified as a result of a customer complaint.

The lots being recalled were distributed to customers and distributors in the United States between June 6, 2015 and December 16, 2015. See the Press Release for affected lot numbers.

Injecting a product containing particulate matter, in the absence of in-line filtration, may result in blockage 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.

BACKGROUND: 0.9% Sodium Chloride Injection, USP, 250 mL VIAFLEX Plastic Container is intended for IV use as a source of water and electrolytes and may also be used as a priming solution in hemodialysis procedures. 70% Dextrose Injection (2000 mL) USP is indicated as a source of calories and water for hydration.

RECOMMENDATION: Baxter is directing customers not to use the product from the recalled lots. 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 a.m. and 6 p.m., Central Time. Unaffected lots of product are available for replacement. This recall is not expected to affect current supply and product remains available for current customers.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch Safety Alert, including links to the press release at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm479948.htm