FDA recall D-0223-2025

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

Reason for recall

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

Distribution

USA nationwide.

Key facts

Status

Ongoing

Initiation date

2024-12-20

Report date

2025-02-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Rochester, MI, United States

Primary source

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