Endo, Inc. (OTCQX: NDOI) has initiated a voluntary recall of all current stocks of Adrenalin® Chloride Solution (EPINEPHrine nasal solution, USP) 30mg/30mL (1mg/mL) due to regulatory issues. The product, distributed under the brand Par Pharmaceutical, is identified as unapproved by the FDA and misbranded with potentially misleading labeling.
The recall targets all batches within their expiration dates of the nasal solution meant for topical application, specifically lot numbers 82809, 79637, 77776, 74716, 71835, and 72916. These were distributed nationwide from October 10, 2023, through December 11, 2024.
The FDA has raised concerns because the product’s packaging closely resembles that of Endo’s FDA-approved Adrenalin® (epinephrine injection, USP) (1mg/mL) 30mL vial. The similarity could lead to dangerous mix-ups between the non-sterile nasal solution and the sterile injectable form, posing severe health risks if administered incorrectly.
Health risks highlighted include serious infections from intravenous use of the non-sterile product and potential life-threatening complications from incorrect dosing during emergency treatment. The recall does not affect the approved injectable form of Adrenalin®.
Endo has reported no adverse events in the last five years and is coordinating the return of the recalled product through Inmar, Inc. Customers and distributors in possession of the recalled lots should halt distribution and use immediately.
Inquiries regarding the recall can be directed to Inmar, Inc. at 1-877-560-8453 or via email at rxrecalls@inmar.com. Medical concerns or adverse reactions can be reported to the FDA’s MedWatch program.
This recall is being conducted with the acknowledgment of the U.S. Food and Drug Administration.
