A reasonable chance it could cause serious harm or death.
Labeling: Not Elsewhere Classified: misleading label similar in appearance to the FDA-approved drug product Adrenalin¿ (epinephrine injection, USP)
| Distributed by / for | Par Pharmaceutical, Chestnut Ridge, NY 10977 |
| NDC | 42023-103-01 |
| Full product label | 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 |
| Recalling firm | ENDO USA, Inc. |
| Distribution | USA nationwide. |
| Quantity | 44,397 amber glass vials |
| Recall initiated | 2024-12-20 |
| Report date | 2025-02-12 |
| Recall completed | — |
| Recall number | D-0223-2025 |
| Classification | Class I |
| FDA status | Ongoing |
| Origin on file | Rochester MI United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗