FDA recall D-0022-2025
Fresenius Kabi Compounding, LLC · Class II · drug
Product
EPINEPHrine 0.9% Sodium Chloride Injection USP, 8 mg per 250 mL Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-060-58
Reason for recall
cGMP violations
Distribution
Product was distributed to 125 direct accounts nationwide.
Key facts
- Status
- Terminated
- Initiation date
- 2024-09-25
- Report date
- 2024-10-30
- Termination date
- 2025-08-15
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Canton, MA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0022-2025