Endo, Inc is voluntarily recalling all lots of Adrenalin® Chloride Solution (EPINEPHrine nasal solution, USP) 30 mg/30 mL vials due to serious safety concerns, the company announced yesterday Dec. 20, 2024.
The recall impacts products distributed nationwide to hospitals and healthcare systems for professional use, following concerns that the solution was never submitted for FDA approval and was misbranded, posing significant risks to patient safety.
The Adrenalin® Chloride Solution, which pre-dates the 1938 Federal Food, Drug, and Cosmetic Act, was discovered by the FDA to be an unapproved drug, and its labeling is misleading.
The product’s packaging is nearly identical to that of Adrenalin® (epinephrine injection, USP), an FDA-approved injectable drug that is used to treat life-threatening conditions like anaphylaxis, hypotension, and cardiac arrest. This similarity in packaging can lead to confusion, with healthcare professionals potentially administering the non-sterile nasal solution intravenously instead of the approved injectable version.
The recalled product, which was distributed from October 10, 2023, through December 11, 2024, is a topical vasoconstrictor for nasal application and is packaged in 30 mL vials under NDC #42023-103-01. The labeling clearly states “Nasal Solution USP” and “For Topical Application,” but its appearance is alarmingly similar to the FDA-approved injectable epinephrine product, increasing the likelihood of administration errors.
This recall impacts the product lots in the below table:
Potential Health Risks
The risk associated with this product is significant. If Adrenalin® Chloride Solution is administered intravenously instead of the sterile injectable version, patients could suffer serious and potentially fatal consequences.
Incorrect dosing of epinephrine in emergency situations—such as the treatment of severe allergic reactions (anaphylaxis), low blood pressure, or cardiac arrest—could lead to delayed or inadequate treatment, infection, or incorrect dosing of the drug, which could be fatal.
Endo has not received reports of adverse events associated with the product in the last five years. However, the company is acting out of an abundance of caution, with the goal of preventing any potential future harm.
Recall Details and Actions
The recall affects all lots of Adrenalin® Chloride Solution (EPINEPHrine nasal solution, USP) that are still within their expiry date. Endo USA, Inc. is notifying all distributors, hospitals, and healthcare providers that received the affected product, and is arranging for the return of all existing inventory through Inmar, Inc.
Healthcare professionals and wholesalers are urged to immediately discontinue use and halt distribution of the recalled product.
Endo is working with Inmar, Inc. to coordinate the return process, and consumers who have received the product should contact Inmar at 1-877-560-8453 or via email at [email protected] for further instructions.
Reporting and Further Information
For questions regarding the recall or to report any adverse reactions or quality concerns related to this product, consumers and healthcare professionals can contact Endo at 1-800-828-9393.
The FDA encourages anyone who experiences adverse effects to report the incident through its MedWatch Adverse Event Reporting program.
In a statement, Endo stressed its commitment to patient safety and regulatory compliance, stating: “We are dedicated to ensuring that our products meet the highest standards and that healthcare professionals have access to the safest possible treatments.”
For media inquiries, Endo’s public relations team can be reached at [email protected].