Drug 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
D-0223-2025
Product summary
- Firm
- ENDO USA, Inc.
- Event
- Event 96013
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 44,397 amber glass vials
- Official record key
drug-enforcement:D-0223-2025
Official wording
Reason: Labeling: Not Elsewhere Classified: misleading label similar in appearance to the FDA-approved drug product Adrenalin¿ (epinephrine injection, USP)
Code information: All lots within expiry
Distribution pattern: USA nationwide.
Derived failure modes
-
Unknown
Labeling: Not Elsewhere Classified: misleading label similar in appearance to the FDA-approved drug product Adrenalin¿ (epinephrine injection, USP)