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Rachel V Thomas

US FDA Recalls Injectables Over Fiberglass, Steel Particles: See Affected Drugs

The US Food and Drug Administration (<span>FDA</span>) has announced recalls of multiple <span>injectable drugs</span> from <span>Baxter International</span> over potential contamination with fiberglass and stainless-steel particles. 

<ul><li>two injections used to provide nutrition, water, and electrolytes to patients. </li><li>an injectable anticoagulant — a substance used to slow blood clotting — was also recalled, but the affected product was distributed to only one customer. </li></ul>

In a notice, the FDA said the medications could be contaminated with fiberglass or stainless-steel particles. Injecting contaminated products intravenously may lead to serious adverse health consequences. 

“Particulate matter can cause blockage and clotting in blood vessels, which can cut off blood flow to vital organs, lead to a life-threatening blood clot in the lungs (pulmonary embolism) and cause permanent organ damage or death,” the FDA said. 

“Additionally, these particles may cause local vein irritation, inflammatory reaction, aggravation of preexisting infections, and allergic 

reactions,” it added. Baxter said it has not received any reports of adverse events related to the issue. 

<h2>Which Medications Were Recalled? </h2>

The recalled Baxter medications include: 

<ul><li>70% Dextrose Injection, USP, 2000 mL, in a Viaflex plastic container. </li></ul><ul><li>0.9% Sodium Chloride Injection, USP, 500 mL, in a Viaflex plastic container. </li></ul><ul><li>Anticoagulant Sodium Citrate Solution USP, 250 mL, in a Viaflex plastic container. The FDA noted that this product was distributed to only one customer. </li></ul>

The 70% Dextrose Injection is a liquid solution mixed with other fluids to provide calories and nutrition through a person's veins when they cannot get necessary nutrients by mouth or through a feeding tube, USA Today reported. 

The impacted products were sold between July 25 and July 28 to healthcare providers and distributors in several states, including Alabama, Georgia and Tennessee.  No adverse reactions have been reported. 

<h2>Water And Electrolyte Injection Recalled</h2>

The 0.9% Sodium Chloride Injection is commonly used as a source of water and electrolytes. It is administered through the veins when a person cannot get adequate amounts through eating, drinking or other medical treatments. 

The injection may also be used during medical procedures, including blood transfusions and hemodialysis, a procedure that helps filter waste from the blood when the kidneys cannot do so adequately. 

The impacted product was distributed between July 31 and August 3 to healthcare providers and distributors in several states, including Florida, Illinois, Indiana, Louisiana, Maryland, Missouri, North Carolina, New Jersey, Nevada, New York, Ohio, South Carolina, Texas and Virginia. No adverse reactions have been reported. 

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The US Food and Drug Administration (FDA) has announced recalls of multiple injectable drugs from Baxter International over potential contamination with fiberglass and stainless-steel particles. Baxter voluntarily recalled:two injections used to provide nutrition, water, and electrolytes to patients. an injectable anticoagulant — a substance used to slow blood clotting — was also recalled, but the affected product was distributed to only one customer. In a notice, the FDA said the medications could be contaminated with fiberglass or stainless-steel particles. Injecting contaminated products intravenously may lead to serious adverse health consequences. “Particulate matter can cause blockage and clotting in blood vessels, which can cut off blood flow to vital organs, lead to a life-threatening blood clot in the lungs (pulmonary embolism) and cause permanent organ damage or death,” the FDA said. “Additionally, these particles may cause local vein irritation, inflammatory reaction, aggravation of preexisting infections, and allergic reactions,” it added. Baxter said it has not received any reports of adverse events related to the issue. Which Medications Were Recalled? The recalled Baxter medications include: 70% Dextrose Injection, USP, 2000 mL, in a Viaflex plastic container. 0.9% Sodium Chloride Injection, USP, 500 mL, in a Viaflex plastic container. Anticoagulant Sodium Citrate Solution USP, 250 mL, in a Viaflex plastic container. The FDA noted that this product was distributed to only one customer. Nutrition Injection RecalledThe 70% Dextrose Injection is a liquid solution mixed with other fluids to provide calories and nutrition through a person's veins when they cannot get necessary nutrients by mouth or through a feeding tube, USA Today reported. The impacted products were sold between July 25 and July 28 to healthcare providers and distributors in several states, including Alabama, Georgia and Tennessee.  No adverse reactions have been reported. Water And Electrolyte Injection RecalledThe 0.9% Sodium Chloride Injection is commonly used as a source of water and electrolytes. It is administered through the veins when a person cannot get adequate amounts through eating, drinking or other medical treatments. The injection may also be used during medical procedures, including blood transfusions and hemodialysis, a procedure that helps filter waste from the blood when the kidneys cannot do so adequately. The impacted product was distributed between July 31 and August 3 to healthcare providers and distributors in several states, including Florida, Illinois, Indiana, Louisiana, Maryland, Missouri, North Carolina, New Jersey, Nevada, New York, Ohio, South Carolina, Texas and Virginia. No adverse reactions have been reported. 

us fda recalls injectables over fiberglass, steel particles: see affected drugs

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