PlainRecalls
FDA Drug Critical Class I Ongoing

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

Reported: February 12, 2025 Initiated: December 20, 2024 #D-0223-2025

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)

Details

Recalling Firm
ENDO USA, Inc.
Units Affected
44,397 amber glass vials
Distribution
USA nationwide.
Location
Rochester, MI

Frequently Asked Questions

What product was recalled?
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. Recalled by ENDO USA, Inc.. Units affected: 44,397 amber glass vials.
Why was this product recalled?
Labeling: Not Elsewhere Classified: misleading label similar in appearance to the FDA-approved drug product Adrenalin¿ (epinephrine injection, USP)
Which agency issued this recall?
This recall was issued by the FDA Drug on February 12, 2025. Severity: Critical. Recall number: D-0223-2025.