ARS PHARMACEUTICALS OPERATIONS, INC.

Nationwide Recall: Unapproved EPINEPHrine Nasal Solution Raises Safety Concerns

- The FDA has initiated a recall of EPINEPHrine nasal solution, USP by Endo due to lack of FDA approval and misbranding concerns, as the product predates the 1938 Federal Food, Drug & Cosmetic Act. - The recall addresses potential safety risks from product confusion with FDA-approved Adrenalin injection, with similar labeling potentially leading to medication errors and life-threatening outcomes in emergency situations. - Six specific lots distributed nationwide between October 2023 and December 2024 are affected, while the FDA-approved Adrenalin injection remains safe for continued use.