Statement follows 2024 report of a patient injected with nasal solution.
Confusion between approved injectable epinephrine products and unapproved nasal solutions has prompted a warning to healthcare providers and a recall by one manufacturer, according to a JanuaryThe warning applies to unapproved epinephrine nasal solutions manufactured by BPI Labs LLC, in Largo, Florida , and Endo USA, in Malvern, Pennsylvania.
“The similarities of the bottle and packaging labels between the nasal product and the sterile injectable make it difficult to distinguish them from each other, which can lead to healthcare professionals accidentally injecting the nasal solution instead of the injection product,” according to the FDA.
Since 2016, the FDA has received more than 25 reports of confusion between the nasal solution and injectable products, including one report in 2024 of a patient who was injected with the nasal solution. Citing the potential for accidental injection, Endo USA recalled its unapproved solution. BPI Labs has not yet recalled its product, despite a recommendation from the FDA, according to the statement.
“I was not aware of this problem prior to the FDA announcement,” said Rabin. “I was surprised to learn that formulations of epinephrine were available with different indications yet overlapping labels,” he added.. However, in addition to clear labeling, communication among healthcare providers is needed to improve safe epinephrine use, said Rabin.
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