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The U.S. Food and Drug Administration (FDA) has issued a warning to healthcare professionals to avoid using unapproved epinephrine nasal solutions produced by BPI Labs LLC and Endo USA. The agency highlighted the potential for confusion between these nasal solutions and FDA-approved injectable epinephrine products, leading to medical errors.
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The unapproved nasal solutions, packaged similarly to their injectable counterparts, have been mistakenly administered intravenously. Such errors are significant because nasal solutions are not required to be sterile, unlike injectable medications. Administering a non-sterile product intravenously increases the risk of severe infections, which can pose life-threatening risks to patients.
Despite these risks, BPI Labs has not complied with FDA recommendations to recall its unapproved nasal solution, even after repeated follow-ups. Conversely, Endo USA voluntarily recalled its unapproved nasal solution in December 2024 to prevent further incidents.
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Since 2016, the FDA has received more than 25 reports of confusion involving these products due to similarities in labeling and packaging. A recent incident in 2024 involved a patient receiving the nasal solution intravenously, underscoring the ongoing dangers of these look-alike products in clinical settings. The FDA continues to urge healthcare professionals to ensure they are using approved products to avoid such mistakes.
Article by multiple RFHC contributors.
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