FDA Warns Against Using Nasal Solutions Containing Epinephrine Made by BPI Labs and Endo USA

Healthcare professionals have been urged by the FDA not to use unapproved epinephrine nasal solutions developed by Endo USA and BPI Labs LLC.

The FDA pointed out that:

• These nasal solution should never be administered intravenously as medical professionals were mistakenly using them for authorized injectable epinephrine preparations meant for intravenous usage.

• The two unapproved epinephrine nasal solutions' packaging and containers appear exactly like those of injectable solutions manufactured by the same companies, which could enable the nasal solutions to be erroneously injected.

• These companies produces injectables and nasal solutions, and due to their identical packaging and containers, it can be difficult to distinguish them apart which might result in healthcare professionals to utilize the nasal solution in their injections.

Further, the FDA said nasal solutions are spared from the sterility requirement that is applicable to injectable solutions. According to the FDA, injecting nonsterile drugs can end up in infections that may turn fatal for certain people.


Endo USA voluntarily recalled its un approved Adrenalin Chloride Solution (Epinephrine Nasal Solution, USP) on December 20, 2024, due to the likelihood of accidental injection.

Although BPI Labs has not yet recalled the drug, the FDA suggested on December 12, 2024, that it must recall its unapproved Epinephrine Nasal Solution. The FDA continued this suggestion to the company numerous times in follow-up communication.

Having similar product labeling and containers, the FDA has received more than 25 reports since 2016 exhibiting confusion between approved epinephrine injection solution and unapproved epinephrine nasal solution.

A patient who received injections with the nasal solution was reported to the FDA in 2024. The product from BPI Labs and its most recent label revision were the subject of the most recent adverse event that was reported to the FDA.

References:

1. U.S. Food and Drug Administration. "FDA Warns Health Care Professionals Not to Use Epinephrine Nasal Solutions from BPI Labs and Endo Pharmaceuticals USA." Accessed January 20, 2025. https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-health-care-professionals-not-use-epinephrine-nasal-solutions-bpi-labs-and-endo-usa

(Input from various sources)

(Rehash/Dr Puja Devi/MSM)