ENDO USA, Inc. recalls Adrenalin Chloride Solution (Epinephrine Nasal Solution, USP), 30mg/30mL (1mg/mL), packaged in 30 mL vials, Distributed
Recalled February 12, 2025 · FDA recall D-0223-2025 · ENDO USA
Hazard
Labeling: Not Elsewhere Classified: misleading label similar in appearance to the FDA-approved drug product Adrenalin¿ (epinephrine injection, USP) · FDA Class I
Units
44,397 amber glass vials
Sold at
USA nationwide.
Description
Labeling: Not Elsewhere Classified: misleading label similar in appearance to the FDA-approved drug product Adrenalin¿ (epinephrine injection, USP)
Product
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
Manufacturer(s)
ENDO USA, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →