← FDA ENFORCEMENT
D-0223-2025Class I

ENDO USA, Inc.

Recalling firm
ENDO USA, Inc.
Product type
Drug
Status
Ongoing
Report date
2025-02-12
Distribution
USA nationwide.
Firm state
MI
Product quantity
44,397 amber glass vials
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Documentation & Change Control
Reason for recall

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

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

Code / lot info

All lots within expiry

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.