Baxter Recalls Sodium Chloride Injections
In mid-December, Baxter International recalled two lots of Sodium Chloride Injection. This particular recall affected 100-ML mini bags and containers of 0.9% sodium chloride. The recall was made voluntarily after the company received reports of particulate matter in the product.
Customers found the contaminant, part of the vial adapter, during routine inspection of the bags before they were administered to patients. Baxter says the product labeling indicates all bags should be inspected before use, if possible.
Lots affected by this recall are P317842, and P317891. Both lots were set to expire in May of this year. If your pharmacy has any of these lots in stock, do not administer to patients. Call Baxter International’s customer service line at 1-888-229-0001 anytime between the hours of 7:00 am to 6:00 pm Central Time, Monday through Friday, to arrange for the product to be returned. Unaffected lots can continue to be used as normal, but are also available for replacement.
According to the FDA, if this solution is used, the particulate could block blood vessels and lead to stroke, heart damage, heart attack, or damage to other vital organs, such as the liver or kidneys. The severity and extent of harm to patients could vary, based on the size, number of composition of the particulate, and the patient’s underlying medical condition. Baxter International says no adverse events associated with this issue have been reported so far, and the issue has been resolved.
If you have questions or concerns about this recall, contact Baxter International at 1-800-422-9837 anytime between the hours of 8:00 am and 5:00 pm Central Time Monday through Friday. Alternatively, customers can email Baxter at OneBaxter@Baxter.com. Patients who believe they have experience issues related to this recall should be instructed to contact their physician or other healthcare provider.
Quality problems or adverse reactions associated with the use of this product can be reported to the FDA’s MedWatch Adverse Reporting System either online by, fax, or by regular mail.
This is not the first time Baxter International has had to recall sodium chloride injections. A single lot of sodium chloride injection IV solution was recalled in June 2014 as a result of particulate matter found close to the administration report. Only a portion of the affected lot in this case was released to customers – only 29 customers received solution belonging to the affected lot. No adverse reports were received as a result of this recall, and the situation was quickly resolved.
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