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Baxter IV Solutions Recalled after Particles Discovered
Qmed Staff
July 17, 2014
2 Min Read
.svg?width=850&auto=webp&quality=95&format=jpg&disable=upscale "Baxter IV Solutions Recalled after Particles Discovered")
By Nancy CrottiBaxter International recently announced that it is voluntarily recalling four lots of intravenous (IV) solutions from hospitals and users because of potentially deadly particulate matter in the solutions. These products contain particulate matter identified as cellulosic fibers and/or plastics, according to a Baxter news release, dated Moday and relayed by the FDA. Baxter received four complaints over a six-month period from customers who saw the particulate matter prior to administration to a patient, according to the new release.If infused, particulate foreign matter could be life-threatening, or elicit inflammatory or allergic responses, either chronic or acute, according to Baxter. There have been no reported illnesses or deaths associated with this issue to date, and Baxter said it is investigating to determine the cause of the contamination. Products affected by this recall are:
0.9 percent Sodium Chloride 100 mL (Quad Pack), lot number P298190, expiration date August 2014, NDC 0338004918;
0.9 percent Sodium Chloride 100 mL MINI-BAG Plus, lot number P308650, expiration date October 2014, NDC 0338055318;
0.9 percent Sodium Chloride, 50 mL (Single Pack), lot number P309187, expiration date October 2014, 0338004914;
Highly Concentrated Potassium Chloride Injection, 20 mEq/50 mL, VIAFLEX Plus Container, lot number P309476, expiration date October 2014, NDC 0338070341.
Baxter distributed the recalled lots worldwide to customers and distributors between February 2013 and June 2014.If infused with IV solution containing the particles, the severity of the inflammatory and allergic reaction would vary depending on the amount of particulate matter injected into the patient, the size of the particles, the patient's underlying medical condition, and the presence of a right-to-left cardiac shunt, according to by Baxter. The reaction could be life-threatening, though. Sodium Chloride Injection, USP is used as a priming solution in hemodialysis procedures, and may be used as a diluent for reconstitution of a powdered drug product. Potassium Chloride Injection is a potassium replacement to support nerve conduction, muscle contraction and prevention of cardiac arrhythmias. More information, including how to contact Baxter over the recall, is available on the <FDA's website.
Nancy Crotti is a contributor to Qmed and MPMN.
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