Drug Enforcement D-0223-2025

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

Status

Ongoing

Classification

Class I

Report Date

February 12, 2025

Termination Date

—

Product Information

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
Product quantity
44,397 amber glass vials
Reason for recall
Labeling: Not Elsewhere Classified: misleading label similar in appearance to the FDA-approved drug product Adrenalin¿ (epinephrine injection, USP)
Recall initiation reason
—
Initial firm notification
Press Release
Distribution pattern
USA nationwide.

Location & Firm

Recalling firm
Endo USA, Inc.
Address
870 Parkdale Rd

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0223-2025
Event ID
96013
Recall initiation date
December 20, 2024
Center classification date
February 5, 2025
Code info
All lots within expiry
More code info
—