Baxter International has issued a voluntary nationwide recall of two lots of 0.9% Sodium Chloride Injection after the potential presence of particulate matter identified as fiberglass was detected in the solution, according to a notice published by the Food and Drug Administration (FDA). The recalled product is commonly used as a source of water and electrolytes in patients receiving intravenous treatment and is also used as a priming solution in hemodialysis procedures. The company said the affected products were distributed to healthcare providers and distributors in 14 states between July 31 and August 3.
Fiberglass contamination in pharmaceutical manufacturing is considered uncommon but possible, rather than a routine or widespread problem. Pharmaceutical facilities use extensive controls, including filtration, environmental monitoring, equipment inspections, and quality-control testing, to prevent foreign particulate matter from entering medicines. However, contamination can occasionally occur through damaged manufacturing equipment, packaging components, filtration systems, or other sources, prompting product recalls when particles are detected.
The Baxter recall illustrates the seriousness of even a potential contamination event in an injectable product, because particles introduced directly into the bloodstream can pose substantially greater risks than contamination in medicines taken by mouth. Newsweek reached out to Baxter via email for comment and is awaiting comment. According to Baxter, the affected lots were distributed in: The company said the recalled saline was shipped to healthcare providers and distributors in those states from July 31 through August 3.
Baxter said it is recalling two lots of 0.9% Sodium Chloride Injection, USP, 500 ml VIAFLEX Plastic Container, due to the potential presence of particulate matter identified as fiberglass in the solution. Both have an expiration date of October 31, 2027. The FDA noted that the presence of fiberglass particles in an IV solution could pose serious health risks if administered intravenously.
According to Baxter's recall notice, intravenous administration of saline containing fiberglass particulate matter may lead to serious adverse health consequences. The company warned that particles entering the bloodstream could cause blockages and clotting in blood vessels, potentially cutting off blood flow to vital organs. In severe cases, this could result in pulmonary embolism, permanent organ damage or death.
The notice also says the particles may cause local vein irritation, inflammatory reactions, aggravation of preexisting infections and allergic reactions. As of August 25, Baxter said it had not received any reports of adverse events related to the issue. Customers have been instructed to stop using and return any affected product in accordance with their facility's procedures.
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