D-0223-2025 Class I Ongoing
FDA drug recall D-0223-2025 was initiated by ENDO USA, Inc. on December 20, 2024 and is designated Class I. Reason for recall: Labeling: Not Elsewhere Classified: misleading label similar in appearance to the FDA-approved drug product Adrenalin¿ (epinephrine injection, USP) The recall status is ongoing. Affected quantity: 44,397 amber glass vials.
Recall Details
- Product Type
- Drugs
- Report Date
- February 12, 2025
- Initiation Date
- December 20, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 44,397 amber glass vials
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)
Distribution Pattern
USA nationwide.
Code Information
All lots within expiry