Adrenalin Chloride Solution (Epinephrine Nasal Solution, USP), 30mg/30mL (1mg/mL), packaged in 30...
FDA Recall #D-0223-2025 — Class I — December 20, 2024
Product Description
Adrenalin Chloride Solution (Epinephrine Nasal Solution, USP), 30mg/30mL (1mg/mL), packaged in 30 mL vials, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC 42023-103-01
Reason for Recall
Labeling: Not Elsewhere Classified: misleading label similar in appearance to the FDA-approved drug product Adrenalin¿ (epinephrine injection, USP)
Recalling Firm
ENDO USA, Inc. — Rochester, MI
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
44,397 amber glass vials
Distribution
USA nationwide.
Code Information
All lots within expiry
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated