| REQUIRED ACTIONS: |
| 1.IMMEDIATELY deploy new inventory upon receipt while simultaneously removing and quarantining all existing inventory of the affected epinephrine vials from kits, vehicles, stations, etc. 2.Box up all removed/quarantined product, affix the attached recall label to the outside of the box, and have available for pickup and return to the EMS Central Supply Warehouse |
| Manufacturer | Product Name | NDC | Product Code | Lot # | Expiration Date |
| Fresenius Kabi Pharmaceuticals | Epinephrine Injection 1 mg/mL, 1 mL Fill Vial | 63323-696-02 | 696125 | Multiple | Multiple |
REASON: Fresenius Kabi has decided to take this action due to physicochemical out-of-specification (OOS) results at the 18-month stability test station
Clinical Impact: The Health Hazard Evaluation concluded an overall low risk to patients. No adverse event reports have been received to date.
