FDA

FDA advises against use of epinephrine nasal solutions from BPI Labs and Endo USA

January 20, 2025

FDA has issued a warning to health care professionals against using unapproved epinephrine nasal solutions manufactured by BPI Labs and Endo USA. These products have been confused with FDA-approved injectable epinephrine due to similar packaging and labeling, leading to accidental IV injections of the nasal solution. Unlike injectable epinephrine, nasal solutions are not required to be sterile, and injecting a non-sterile product can result in life-threatening infections. Despite FDA recommendations, BPI Labs has not recalled its product, while Endo USA voluntarily recalled its nasal solution in December 2024. FDA has received over 25 reports of such confusion since 2016. The agency encourages HCPs and patients to report adverse events or quality problems experienced with the use of any medication to FDA’s MedWatch Adverse Event Reporting program.

Source:

(2025, January 16). FDA. FDA warns health care professionals not to use epinephrine nasal solutions from BPI Labs and Endo USA. https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-health-care-professionals-not-use-epinephrine-nasal-solutions-bpi-labs-and-endo-usa