Adrenalin Recalled

On Dec. 20, 2024, Endo, Inc., the parent company of Par Pharmaceutical, recalled six lots of Adrenalin^® Chloride Solution (Epinephrine nasal solution, USP) 30mg/30mL (1mg/mL) 30 mL vials, to the consumer level. The FDA has determined that the labeling is misbranded and easily confused with the injectable version of Adrenalin^® (Epinephrine injection, USP) (1mg/mL) 30mL vial, also produced by the same company. Adrenalin Chloride Solution (Epinephrine nasal solution) is used for topical application following mucosal or sinus surgery. The recall is being carried out because labeling makes it hard to distinguish from the injectable version of the drug, which could lead to the injection of a non-sterile product. Intravenous administration of a non-sterile nasal product could lead to serious health outcomes, including delayed treatment for conditions like anaphylaxis and also the increased risk of infection. There's also a high risk of administering an incorrect dose of epinephrine in emergencies, putting patients at risk of death if not treated properly. For more information, see here.