Epinephrine Nasal Solutions by BPI Labs and Endo USA: CDER Alert – FDA Warns Health Care Professionals Not to Use *
TOPIC: Epinephrine Nasal Solutions by BPI Labs and Endo USA: CDER Alert – FDA Warns Health Care Professionals Not to Use 😨💊 #HealthCareProfessionals #FDAWarnings
AUDIENCE: Patient, Health Care Professional, Pharmacy
📢 Healthcare professionals need to be alert ⚠️ using unapproved epinephrine nasal solutions made by BPI Labs LLC and Endo USA. These products are similar to FDA-approved injectable epinephrine products for intravenous use. Never inject these products intravenously! #HealthcareSafety #AvoidInjections 🚫💉🚑
The nasal solution and injectable products share similar packaging containers. Some were manufactured by the same manufacturers. The similarities between the bottle and packaging labels of the nasal product and the sterile injectable product can lead to a misinterpretation, resulting in healthcare professionals inadvertently administering 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 😷💉🚫 #HealthAwareness #NonsterileDrugs.
Health care professionals use both products in hospitals and health care settings. 🏥👩⚕️🏥
The FDA has received over 25 reports since 2016, highlighting discrepancies between the unapproved epinephrine nasal solution and approved epinephrine injection, with similarities in product labels and containers. Recently, in 2024, the agency received a report pertaining to a patient who received the nasal solution as an injection. (Federal department of Ageiculture 01/2025)
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.
📢Calling all Health Care Professionals, Patients and Consumers, Report if you’ve experienced any problems or know of someone whom has experienced problems with these products.
You can do this by reporting them to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.🚨