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
This recall is currently active, issued February 12, 2025. It was issued by Endo Usa, Inc..
- Company
- Endo Usa, Inc.
- Recall Initiated
- December 20, 2024
- Posted
- February 12, 2025
- Recall Number
- D-0223-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 44,397 amber glass vials
- Firm Location
- Rochester, MI, United States
- Official Source
- View on FDA website ↗
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.
Lot / Code Info
All lots within expiry
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