Adrenalin® Chloride Solution (EPINEPHrine nasal solution, USP)
Product details
- Adrenalin® Chloride Solution (EPINEPHrine nasal solution, USP)
Company announcement
Endo USA, Inc. is voluntarily recalling all lots within expiry of Adrenalin® Chloride Solution (EPINEPHrine nasal solution, USP) due to the potential for administration errors.
The product is an unapproved drug with a misleading label similar to the FDA-approved Adrenalin® (epinephrine injection, USP).
The recalled product was distributed nationwide from October 10, 2023, through December 11, 2024.
Risk:
Intravenous administration of the unapproved non-sterile topical Adrenalin® Chloride Solution (EPINEPHrine nasal solution, USP), instead of the approved sterile Adrenalin® (epinephrine injection, USP) (1mg/mL) 30mL vial for injection, 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. In addition, 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 such as the treatment of anaphylaxis, blood pressure support, and cardiac arrest. If these events are not treated with the correct dose of epinephrine, patients may be at risk for death.
Impacted states: Nationwide
Products:
- Adrenalin® Chloride Solution (EPINEPHrine Nasal Solution, USP) for topical application 30mg/30mL (1mg/mL)
Contact
For more information, call 1-877-560-8453.