FDA

Endo USA recalls Adrenalin Chloride Solution due to potential administration errors

December 27, 2024

Endo USA, Inc. has issued a voluntary nationwide recall of all lots of Adrenalin Chloride Solution (EPINEPHrine nasal solution, USP) 30mg/30mL (1mg/mL) due to potential administration errors. This product, which predates the 1938 Federal Food, Drug & Cosmetic Act, was never FDA-approved and is misbranded with a label similar to the FDA-approved Adrenalin® (epinephrine injection, USP) 30mL vial.

The recall affects products distributed to hospitals and healthcare systems, where the similarity in labeling could lead to confusion between the non-sterile nasal solution and the sterile injectable product. IV administration of the nasal solution could result in serious health outcomes, including delayed treatment of anaphylaxis, hemodynamic instability, hypotension, or infection. No adverse events have been reported in the past five years.

Source:

FDA. (2024, December 20). Endo USA, Inc. Issues Voluntary, Nationwide Recall of Adrenalin Chloride Solution (EPINEPHrine Nasal Solution, USP) Due to the Potential for Administration Errors. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/endo-usa-inc-issues-voluntary-nationwide-recall-adrenalinr-chloride-solution-epinephrine-nasal