July 22, 2015
0.9 Percent Sodium Chloride Injection, USP, 50mL and 100mL by Baxter: Recall - Particulate Matter
AUDIENCE: Risk Manager, Pharmacy, Nursing
ISSUE: Baxter International Inc. announced it is voluntarily recalling two lots of intravenous (IV) solutions to the hospital/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 matter was identified prior to patient administration and there have been no adverse events associated with this issue reported to Baxter.
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.
This recall affects Lot Numbers P319921 and P327635.
BACKGROUND: The lots being recalled were distributed to customers and distributors in the United States between October 7, 2014, and July 14, 2015.
RECOMMENDATION: Baxter is directing customers not to use 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 7:00 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 a.m. and 5 p.m. Central Time, or email Baxter at [email protected]. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using these drug products.
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/ucm455421.htm
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