TOPIC: Epinephrine Nasal Solutions by BPI Labs and Endo USA: CDER Alert - FDA Warns Health Care Professionals Not to Use
AUDIENCE: Patient, Health Care Professional, Pharmacy
ISSUE: FDA is warning health care professionals not to use unapproved epinephrine nasal solutions manufactured by BPI Labs LLC and Endo USA. 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 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.
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.
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.
For more information about this alert, click on the red button "Read Alert" below.
BACKGROUND: 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.
FDA recommended BPI Labs recall its unapproved EPINEPHrine Nasal Solution on Dec. 12, 2024. The agency 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.
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