Similarities in bottle and packaging labels between unapproved nasal and FDA-approved injectable epinephrine products make it difficult to distinguish them, risking accidental injections of the nasal solution.
RT’s Three Key Takeaways:
- Label Confusion Creates Risks: The FDA warns that similar labels and packaging between unapproved nasal and FDA-approved injectable epinephrine products could lead to accidental injections of non-sterile nasal solutions.
- Voluntary Recall and Noncompliance: Endo USA voluntarily recalled its unapproved nasal epinephrine solution in December 2024, but BPI Labs has not complied with the FDA’s recommendation to remove its product from the market.
- Reported Adverse Events: The FDA has received over 25 reports of confusion between these products since 2016, including a recent 2024 case where a nasal solution was mistakenly injected.
The US Food and Drug Administration (FDA) is warning health care professionals not to use unapproved epinephrine nasal solutions manufactured by BPI Labs LLC, in Largo, Fla, and Endo USA, in Malvern, Pa.Â
Health care professionals have confused these products with FDA-approved injectable epinephrine products for intravenous use. BPI Labs and Endo USA nasal solutions products should never be injected intravenously, the FDA notes in a drug safety notice.
The nasal solution and injectable products have similar packaging and containers and are manufactured by the same companies. 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 health care professionals accidentally injecting the nasal solution instead of the injection product. Photos of the labeling can be seen here.
[FDA Approves First Epinephrine Nasal Spray for Anaphylaxis]
Unlike an injectable drug, nasal solutions are not required to be sterile. Injecting a non-sterile drug can lead to infection, which can be life threatening for certain patients. Health care professionals use both products in hospitals and health care settings.
Label Confusion Prompts Epinephrine Recall by Endo USA; FDA Urges BPI Labs to Act
Endo USA voluntarily recalled on Dec 20, 2024, its unapproved Adrenalin Chloride Solution (epinephrine nasal solution, USP) due to the potential for health care professionals accidentally injecting the nasal solution instead of the injection product.
The FDA recommended BPI Labs recall its unapproved EPINEPHrine Nasal Solution on Dec 12, 2024. The agency says it followed up with the company several times to reiterate this recommendation. The latest adverse event report FDA received involved the product with BPI Labs’ most recently revised label. The company has not acted to remove its unapproved drug from the market.
The FDA has received more than 25 reports since 2016 stating confusion between unapproved epinephrine nasal solution and approved epinephrine injection involving similarities in product labels and containers. Recently in 2024, the agency received a report involving a patient who received the nasal solution as an injection.
The FDA encourages health care professionals and patients to report adverse events or quality problems experienced with the use of any medication to FDA’s MedWatch Adverse Event Reporting program.