Endo USA has recalled all unexpired lots of Adrenalin Chloride Solution epinephrine nasal solution, which is meant for topical application, due to FDA concerns about the potential for confusion of the product with the company’s Adrenalin epinephrine for injection. As a result of the potential for confusion, Endo said, “FDA has determined the product to be misbranded with a misleading label.” Both the sterile solution for injection, which is FDA approved, and the non-sterile nasal solution are distributed in 30 mL vials to healthcare systems, including hospitals.
According to Endo, the nasal solution “which pre-dates the 1938 Federal Food, Drug & Cosmetic Act, was never submitted for approval by the FDA, and as such, is an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.”
The recall announcement states that injection of the nasal solution “would result in non-fatal serious and/or severe, health outcomes related to delayed or inadequate treatment of the underlying condition (anaphylaxis, hemodynamic instability, hypotension) or infection due to intravenous administration of a non-sterile product” and also that “there is a high probability that intravenous administration of the nasal product will result in patients receiving the wrong dose of epinephrine in emergency situations for serious, life-threatening conditions,” which could be fatal. Endo noted that it “has not received reports of adverse events in the last five years.”
Read the Endo press release
