FDA-Drug2025-02-12Class I

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

ENDO USA, Inc.
Hazard

Labeling: Not Elsewhere Classified: misleading label similar in appearance to the FDA-approved drug product Adrenalin¿ (epinephrine injection, USP)

Sold states
USA nationwide.
Affected count
44,397 amber glass vials
Manufactured in
870 Parkdale Rd, Rochester, MI, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0223-2025

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